On June 10, 2019 Enzo Biochem, Inc. (NYSE:ENZ), an integrated life sciences company focused on commercializing innovative diagnostic and therapeutics products, reported results for the fiscal quarter and nine months ended April 30, 2019 (Press release, Enzo Biochem, JUN 10, 2019, View Source [SID1234536970]). The Company updated the market on the progress of its short-term growth and profitability initiatives designed to unlock value.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Financial Results

·Third quarter net income was $22.3 million, or $0.47 per share including $28.9 million in net legal settlements, on revenues of $19.7 million. This compared to a year ago net loss of $3.0 million, or $0.06 per share when there were no similar settlements. On a sequential basis, revenue increased nearly 2%, and Non-GAAP net loss improved by approximately $1.7 million, or 21%.
·Fiscal third quarter 2019 results reflect the combined impact of continuing reduced insurance reimbursement payments at rates lower than a year ago and reduced genetic test volume, while total diagnostic testing volume, measured by the number of accessions, was up 1% year over year and 3% sequentially to the second fiscal quarter due to increases in esoteric testing. Cash and cash equivalents at the end of the quarter was $64 million and working capital was $71 million.

Strategic Short-Term Initiatives

The Company reiterated the three core pillars of its value creation strategy which are all expected to have a positive impact by the end of calendar 2019.

Forming Strategic Relationships for Diagnostic Growth

Enzo is in active discussions with several leading global life sciences and medical device companies, as well as manufacturers of automated systems to develop strategic relationships in three key platforms pioneered by Enzo’s proprietary products and intellectual property: molecular diagnostics, immunohistochemistry and the Company’s Elisa platform. The discussions involve developing long-term relationships in automation and manufacturing, distribution and marketing and product sales.

Enzo’s goal is to announce at least one of these relationships by the end of calendar 2019.

Building a New Model for the Diagnostic Marketplace

As a lower cost and vertically integrated manufacturer and service provider of molecular testing in the US, Enzo is rolling out a new business model for its labs to labs business whereby Enzo will serve as the "central capability" for smaller labs, capitalizing on its scale in high value and lower cost operations, proprietary intellectual property and products, decades of innovation and commitment to medical solutions.

Response of labs has been positive and Enzo anticipates announcing the formal roll out of this program by the end of calendar 2019.

Return to Operating Profitability and Growth in the Lab Segment

Enzo is focused on returning its lab segment to profitability and growth in three significant ways. Enzo is working aggressively to control operational costs in its lab segment, which has been negatively impacted by a declining reimbursement environment, through, amongst others, consolidating supply chain functions, as well as reorganization and alignment of customer support teams to create greater efficiencies without sacrificing service levels. The Company is also developing a series of compelling growth initiatives that capitalize on our strong intellectual property and integrated approach to manufacturing, which can be offered as either product or services. Finally, Enzo will continue to pursue, through licensing, business development and litigation, revenue opportunities derived from strong intellectual property development and innovation throughout the Company. While Enzo cannot predict the outcome of ongoing patent infringement litigation, the Company believes that its history of settlements and business relationships will continue to help fund our business and growth initiatives.

We expect to see meaningful sequential quarterly cost reduction improvement throughout fiscal 2020, and assuming no further changes in reimbursement programs, with a return to operating profitability at the labs in early calendar 2020.

Elazar Rabbani, Chairman and Chief Executive Officer, Comments:

"Enzo is poised to leverage and capitalize on our deep-rooted, proprietary technology, product development and intellectual property portfolio in very real, short-term strategic initiatives designed to unlock the value we know exists across our business. The Board and the management team are aligned in our belief that we can be an agent of change and transformation in our industry, delivering tangible benefits for our customers, partners, colleagues and shareholders. We know there is tremendous value in our Company not reflected in today’s market and believe that the programs highlighted in today’s announcement underscore our commitment in our business and its prospects.

We are outlining our three-prong value creation strategy: developing strategic relationships, building a new market for the diagnostic marketplace and further reducing operating costs.

We are focused on growth, in both the short and long-term. We are gratified by the interest we are receiving from a number of industry leaders in the life sciences and medical device industries to engage in discussions with us. These companies recognize our vision for the future of the diagnostic marketplace and our commitment to platforms and services.

This growth strategy embraces development of our high volume and lower cost tests used in connection with our proprietary and affordable open system platforms capable of high throughput to improve financial margins at clinical laboratories. We believe we are uniquely positioned to drive change.

At the same time, we have launched an intensive cost cutting and heightened efficiency program that will achieve greater integration of our Company’s financial and operating performances. We anticipate sequential quarterly improvement and a return to operating profitability in our lab in early calendar 2020.

The Company continues to operate on solid financial footing – with, at April 30, 2019, over $64 million in cash and cash equivalents and working capital of almost $71 million, allowing us to comfortably fund the realistic goals we have set out for Enzo."

Third Quarter Operating Results

·Total revenues were $19.7 million, compared to $25.2 million in the prior year, a decrease of $5.5 million or 22%, while improving nearly 2% sequentially from the second fiscal quarter of 2019. Clinical services revenues were $11.7 million, compared to $17.7 million in the prior year, a decrease of $6.0 million, largely due to the aforementioned reduced insurance reimbursement payments, insurance company claims rejections and changes to medical and procedural requirements for genetic testing by payors. Enzo’s AMPIPROBE woman’s health panel has increased in volume each quarter since its launch last fiscal year. Product revenue was $7.9 million compared to $7.4 million in the prior year. Product gross profit was $4.5 million and gross margins were 57%, a 15% increase over the prior year period.
·Clinical services revenues for the three and nine months ended April 30, 2018, reflect adoption of new revenue recognition rules on a full retrospective basis. Under the new rules, Enzo reports uncollectible balances associated with patient responsibility as a reduction in net revenues; historically these amounts were separately classified in operating expenses as a

provision for uncollectable accounts receivable, and amounted to $0.8 million and $0.4 million in the three months ended April 30, 2019 and 2018, respectively, and $2.0 million in both nine month periods.

·Consolidated gross margins were 27% compared with 42% in the prior year, and up from 24% from the second fiscal quarter of 2019. Clinical services gross margins were 7% compared to 38% a year ago and 1% lower sequentially to last quarter. Gross margins in the current year period were negatively impacted by lower reimbursement revenue from Clinical Services. Products gross margin was 57% compared to 53% in the prior year period and 50% in the preceding quarter.
·Operating expenses totaled $11.9 million, compared to $13.5 million a year ago, a decrease of $1.6 million or 12%. Total legal expenses were $0.3 million compared to $1.7 million in the prior year. Selling and general administrative expenses (SG&A) as well as research and development (R&D) expenses were essentially flat year over year.
·During the quarter, the Company recorded legal settlements and licensing payments, net of $28.9 million related to a patent infringement and contract case in New York and an unrelated patent infringement case in Delaware.
·GAAP net income was $22.3 million or $0.47 per share compared to a GAAP net loss of $3.0 million or $0.06 per share in the prior year. The non-GAAP net loss was $6.7 million or $0.14 per share compared to a non-GAAP net loss of $3.0 million or $0.06 per share a year ago. EBITDA in the quarter was $22.8 million and adjusted EBITDA was a loss of $6.1 million.

Nine-month Operating Results

Total revenues were $60.2 million compared to $78.3 million in the prior year, a decline of $18.1 million or 23% lower than prior year. Gross profit totaled $16.9 million, compared to $32.7 million a year ago, with gross margins of 28% and 42%, respectively. SG&A of $33.3 million increased a modest $0.3 million over the prior year. Legal expenses were $2.7 million, down from $3.8 million a year ago. The GAAP net income and Non-GAAP net loss totaled $7.9 million, or $0.17 per share and $21 million or $0.45 per share, respectively. EBITDA for the nine months ended April 30, 2019 was $9.5 million and Adjusted EBITDA was a loss of $19.4 million.

Conference Call

The Company will conduct a conference call Tuesday, June 11, 2019 at 8:30 AM ET. The call can be accessed by dialing (888) 459-5609. International callers can dial (973) 321-1024. Please reference PIN number 2037608.

Interested parties may also listen over the Internet at: View Source

To listen to the live call, individuals should go to the website at least 15 minutes early to register, download and install any necessary audio software. Any pop up blocker installed on your PC should be disabled while accessing the webcast. A rebroadcast of the call will be available starting approximately two hours after the conference call ends, through June 25, 2019. The replay of the conference call can be accessed by dialing (855)-859-2056. International callers can dial (404) 537-3406), and when prompted, used the same PIN number 2037608.

Adjusted Financial Measures

To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley Act, Enzo Biochem attached to this news release and will post to the Company’s investor relations web site (www.enzo.com) any reconciliation of differences between GAAP and Adjusted financial information that may be required in connection with issuing the Company’s quarterly financial results.

The Company uses EBITDA as a measure of performance to demonstrate earnings exclusive of interest, taxes, depreciation and amortization. Adjustments to EBITDA are for items of a non-recurring nature and are reconciled on the table provided. The Company manages its business based on its operating cash flows. The Company, in its daily management of its business affairs and analysis of its monthly, quarterly and annual performance, makes its decisions based on cash flows, not on the amortization of assets obtained through historical activities. The Company, in managing its current and future affairs, cannot affect the amortization of the intangible assets to any material degree, and therefore uses EBITDA as its primary management guide. Since an outside investor may base its evaluation of the Company’s performance based on the Company’s net loss not its cash flows, there is a limitation to the EBITDA measurement. EBITDA is not, and should not be considered, an alternative to net loss, loss from operations, or any other measure for determining operating performance of liquidity, as determined under accounting principles generally accepted in the United States (GAAP). The most directly comparable GAAP reference in the Company’s case is the removal of interest, taxes, depreciation and amortization.

We refer you to the tables attached to this press release which includes reconciliation tables of GAAP to Adjusted net income (loss) and EBITDA to Adjusted EBITDA.

On June 10, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that findings from a new real-world study show that the company’s Afirma Genomic Sequencing Classifier (GSC) helps to identify significantly more benign thyroid nodules and further reduce unnecessary surgeries in thyroid cancer diagnosis, as compared to the original Afirma test (Press release, Veracyte, JUN 10, 2019, View Source [SID1234536969]). Findings from the clinical utility study, conducted by researchers at The Ohio State University, appear online in the journal Thyroid and add to the growing body of independent evidence demonstrating the performance of the next-generation genomic test.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the study, researchers evaluated records for all patients whose thyroid nodules were indeterminate for cancer based on cytopathology and who subsequently underwent molecular testing with the Afirma GSC or the original Afirma Gene Expression Classifier (GEC) between February 2011 and December 2018. Based on a cohort of 164 Afirma GSC-tested nodules and 343 Afirma GEC-tested nodules, they found that the next-generation test identified 58 percent more nodules as benign (76.2 percent vs. 48.1 percent) and that the rate of surgery among indeterminate thyroid nodules decreased by 66.4 percent (from 52.5 percent with the Afirma GEC to 17.6 percent with the Afirma GSC). The "benign call" rate among Hürthle cells – a common but difficult-to-diagnose thyroid nodule subtype – was also significantly higher using the Afirma GSC (88.8 percent vs. 25.7 percent).

"Our findings show that use of the Afirma GSC has enabled us to identify many more patients as benign when their thyroid nodules were indeterminate compared to the original test and, as a result, to help significantly reduce unnecessary thyroid surgeries among these patients," said Jennifer A. Sipos, M.D., endocrinologist and professor at The Ohio State University and an author of the new study. "The next-generation test’s results were particularly striking for patients with Hürthle cells who previously had little other choice than to undergo diagnostic surgery, which carries risks and is costly."

The new study marks the third recent independent publication by a major medical center demonstrating that its use of the Afirma GSC helped to significantly reduce surgeries in thyroid cancer diagnosis.

"These findings clearly demonstrate that, as compared to our original test, our Afirma GSC is delivering even more value to patients who are undergoing evaluation for thyroid cancer, as well as to physicians and the healthcare system," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "This study further underscores the power of our next-generation RNA whole-transcriptome sequencing and machine learning platform to answer important clinical questions that help guide a patient’s medical journey."

On June 10, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported an update on its clinical pipeline and financial results for the fiscal second quarter ended April 30, 2019 (Press release, Advaxis, JUN 10, 2019, View Source [SID1234536968]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key updates on the progress of the company’s clinical pipeline include the following:

ADXS-NEO: Personalized, Neoantigen-Directed Therapy – The company is currently enrolling patients in its Phase 1 dose-escalation study to evaluate ADXS-NEO, a personalized neoantigen-directed immunotherapy designed to activate a patient’s immune system in a range of cancers. The company presented safety, tolerability and immune correlative data from this study at the American Association of Cancer Research ("AACR") Annual Meeting in March, and updated findings were presented at the Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) at the New York Academy of Sciences ("NYAS") in May. The study’s preliminary data demonstrated anti-tumor immune activation, including T-cell responses to neoantigens and antigen spreading, within one week after the first dose. In addition, data from two microsatellite-stable ("MSS") colorectal cancer patients dosed with ADXS-NEO at 1×108 CFU demonstrated increased CD8+ T-cell infiltration in the tumor microenvironment after three doses of ADXS-NEO. Metastatic MSS colorectal cancer is considered to be a "cold" tumor type and typically exhibits little CD8+ T-cell infiltration and resistance to immunotherapy, yet both MSS patients had their "cold" tumors successfully transition into "hot" tumors with ADXS-NEO therapy. Further, two patients (one treated at 1×109 and one at 1×108 CFU) achieved stable disease in the study per RECIST 1.1 criteria.
ADXS-HOT: Cancer Type-Focused Hotspot/Off-the-Shelf Neoantigen-Directed Therapies – ADXS-HOT is a program consisting of over 10 different cancer-type specific immunotherapy constructs, which target hotspot mutations, cancer testis antigens and oncofetal antigens. The first drug candidate from this program, ADXS-503, is designed to treat most types of non-small cell lung cancer and is in a Phase 1/2 clinical trial. One site is currently activated and enrolling patients with a second site anticipated to be activated by the end of June. The study will determine the recommended dose, safety, tolerability and immune and clinical activity of ADXS-503 administered alone and in combination with a checkpoint inhibitor. Preliminary data from this Phase 1/2 study are anticipated in the second half of 2019. The company plans to file INDs on two additional HOT constructs within the next nine months.
ADXS-PSA: Prostate Cancer – The company presented updated clinical and biomarker data at the AACR (Free AACR Whitepaper) Annual Meeting in April on its Phase 1/2 KEYNOTE-046 study of ADXS-PSA, alone and in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, for patients with metastatic castration-resistant prostate cancer ("mCRPC"). In addition, updated findings presented at the Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) at the NYAS in May demonstrated clinical activity and prolonged overall survival in MSS mCRPC patients, who typically are not expected to respond to treatment of a checkpoint inhibitor.
ADXS-HPV: Cervical Cancer – In May, the U.S. Food and Drug Administration ("FDA") lifted its partial clinical hold on the Phase 3 AIM2CERV study evaluating ADXS-HPV ("AXAL") for the treatment of patients with high-risk, locally advanced cervical cancer. The company is in discussions with the FDA to allow for an earlier interim analysis for efficacy under proposed revisions to the AIM2CERV protocol.
Management Commentary

"We are very encouraged by the early and promising data from our first neoantigen-directed immunotherapy, ADXS-NEO," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Based on these results, we continue to believe neoantigen-directed immunotherapies can become an important addition to the cancer treatment paradigm due to the unique presentation of neoantigens in cancer cells. The results from our ADXS-NEO program have shown the ability to have an impact within the tumor microenvironment in metastatic colorectal cancer, which historically has been a tumor type that is refractory to immunotherapy. We look forward to starting Part B of the study with ADXS-NEO in combination with a checkpoint inhibitor in the third quarter of this year."

"We have used the valuable insight we have gained from our ADXS-NEO platform to further advance our ADXS-HOT drug constructs. We are in discussions with a leading academic institution to finalize an investigator-sponsored trial evaluating ADXS-HOT in patients with prostate cancer, and anticipate the IND for this construct will be filed later this year." He added, "In order to ensure we have the appropriate resources to fund our programs, we have taken cost-control measures over the past year. These efforts have resulted in a reduction to our cash burn of more than 50% for the first six months of fiscal year 2019 versus the comparable period last year." He concluded, "We are actively reviewing our plans to finance the areas of the business where we feel there is a strong likelihood of us achieving our mission of improving the lives of people with cancer and their loved ones."

Fiscal Second Quarter Financial Results

Research and development expenses for the second quarter of fiscal year 2019 were $6.0 million, compared with $10.4 million for the second quarter of fiscal year 2018. The $4.4 million decrease was primarily attributable to cost controls initiated in the second half of fiscal year 2018. In addition, there was a decrease in clinical trial expenses resulting from the partial clinical hold on AIM2CERV and the winding down of several older studies, partially offset by an increase in expenses related to the startup costs associated with the commencement of the Phase 1/2 ADXS-HOT clinical trial.

General and administrative expenses for the second quarter of fiscal year 2019 decreased 37% to $3.1 million from $4.9 million for the second quarter of fiscal year 2018. The $1.8 million decrease was primarily attributable to a reduction in headcount and in professional and consulting fees related to external strategy and program assessment work performed in fiscal 2018.

Revenue decreased approximately $0.5 million to $1.2 million for the second quarter of fiscal 2019 from $1.7 million for the second quarter of 2018 due to the termination of the collaboration agreement with Amgen effective February 2019. Net loss for the second quarter of fiscal year 2019 was $9.4 million or $1.59 per share, compared with a net loss for the second quarter of fiscal year 2018 of $13.4 million or $4.03 per share.

Net cash used during the six months ended April 30, 2019 was $11.4 million. As of April 30, 2019, Advaxis had cash and cash equivalents of $33.7 million, which includes $9.0 million in net proceeds from a public offering completed in April.

Conference Call

The company will host a business update call on Tuesday, June 11, 2019 at 11:00 a.m. ET. During the call, Advaxis’ senior management will review the company’s clinical development programs and fiscal second quarter financial results, and provide a general business update.

The conference call and live audio webcast information is as follows:

WHEN: Tuesday, June 11, 2019 at 11:00 a.m. ET
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 6199489
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning June 11, 2019 two hours after the completion of the call. To access the recording, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the operator with the conference ID: 6199489. In addition, an audio webcast will be archived on the Company’s website for a period of time at www.advaxis.com.

On June 10, 2019 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company is scheduled to present at the Goldman Sachs Global Healthcare Conference in Rancho Palos Verdes, California on Tuesday, June 11, 2019 at 2:40 p.m. PT (Press release, Agios Pharmaceuticals, JUN 10, 2019, View Source [SID1234536967]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

On June 10, 2019 The U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as "BR"), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies (Press release, US FDA, JUN 10, 2019, View Source [SID1234536966]). Polivy is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer. This type of therapy, unlike traditional chemotherapy, is intended to target specific cells," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked."

More than 18,000 people are diagnosed with DLBCL each year in the U.S. Although it can be cured, about 30 to 40% of patients suffer relapse. This type of cancer grows quickly in the lymph nodes and may affect the bone marrow, spleen, liver or other organs. Signs and symptoms of DLBCL may include swollen lymph nodes, fever, recurring night sweats and weight loss.

Polivy is an antibody that is attached to a chemotherapy drug. Polivy binds to a specific protein (called CD79b) found only on B cells (a type of white blood cell), then releases the chemotherapy drug into those cells. Efficacy was evaluated in a study of 80 patients with relapsed or refractory DLBCL who were randomized to receive Polivy with BR or BR alone. Efficacy was based on complete response rate and duration of response (DOR), defined as the time the disease stays in remission. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least six months and 12 (48%) had a DOR of at least 12 months.

The most common side effects of Polivy plus BR include low levels of white blood cells (neutropenia), platelets (thrombocytopenia) and red blood cells (anemia); nerve damage (peripheral neuropathy); fatigue; diarrhea; fever; decreased appetite; and pneumonia.

Health care professionals are advised to monitor patients closely for infusion-related reactions, low blood counts and fatal and/or serious infections. Health care professionals should also monitor patients for tumor lysis syndrome (a complication from many tumor cells being killed off at the same time), liver damage (hepatotoxicity) and progressive multifocal leukoencephalopathy (PML), a fatal or life-threatening infection of the brain. FDA advises health care professionals to tell females of reproductive age to use effective contraception during treatment with Polivy and for three months after the last dose. Women who are pregnant or breastfeeding should not take Polivy because it may cause harm to a developing fetus or newborn baby.

Polivy in combination with BR was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on an endpoint that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Polivy’s clinical benefit.

The FDA granted this application Breakthrough Therapy and Priority Review designations. Polivy also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Polivy to Genentech.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

#