On April 1, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease (PD) and related disorders inside and outside of the brain, reported financial results for the fourth quarter and full year ended December 31, 2020 and highlighted recent developments (Press release, Inhibikase Therapeutics, APR 1, 2021, View Source [SID1234577525]).

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Key Business and Clinical Highlights

Completed Initial Public Offering: In December 2020, Inhibikase successfully completed its initial public offering (IPO) of 1,800,000 shares of common stock at a public offering price of $10.00 per share. The Company received aggregate net proceeds of approximately $14.60 million after deducting offering costs, underwriting discounts and commissions.

Commenced Dosing of Patients in Phase 1 Study of IkT-148009 for the treatment of PD and associated GI Disorders: In February 2021, Inhibikase commenced patient dosing in older and elderly healthy volunteers in a Phase 1 randomized single ascending dose and multiple ascending dose study to determine the safety, tolerability and pharmacokinetics of IkT-148009. IkT-148009 is a novel brain penetrant Abelson tyrosine kinase, or c-Abl, inhibitor intended to be used to modify Parkinson’s disease and its gastrointestinal complications.

Accelerated timelines for completion of the Phase 1 trial and initiation of dosing in PD patients. Early data from this study have led to a reduction in the timelines for completion of the study by 6 or more months, providing the opportunity to obtain regulatory approval to commence dosing of PD patients much earlier than previously anticipated.

Commenced chronic toxicology studies of IkT-148009 to permit long-term dosing in patients. In January, 2021 Inhibikase commenced 3 month and 6 month long-term toxicology studies of IkT-148009 in rats and 3 month and 9 month long-term toxicology studies of IkT-148009 in monkeys as required to obtain regulatory approval for chronic administration of IkT-148009 in patients. These studies are expected to be completed in the fourth quarter of 2021.

Commenced clinical batch manufacturing and pill formulation of IkT-001Pro in preparation for an Investigational New Drug application filing in the second quarter of 2021. In February, 2021 Inhibikase commenced clinical batch manufacturing and final product formulation of IkT-001Pro as a film-coated tablet in preparation for regulatory filing with the Food and Drug Administration to initiate clinical development. This regulatory filing is anticipated to be completed near the end of the second quarter of 2021, with initiation of clinical development 30 days after the filing, subject to FDA agreement and issuance of a Study May Proceed notification.
"2020 was a transformative year for Inhibikase, as we successfully completed our IPO and worked diligently to advance our novel programs to treat neurodegenerative diseases towards the clinic," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "Just recently, we were pleased to announce the advancement of our lead candidate, IkT-148009, into a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics in elderly volunteers. Early data from this study has been encouraging and we are shortening the timeline to completion by six or more months, with an expectation to move into early patient studies this year. We believe that IKT-148009 could be a transformative therapy for millions of Parkinson’s patients worldwide. Simultaneously, we have advanced our oncology clinical candidate, IkT-001Pro, into manufacturing and expect to initiate clinical development early in the third quarter. Our highly dedicated team has exceeded all of our internal expectations to move these clinical programs forward for the benefit of patients."

Fourth Quarter and Full Year 2020 Financial Review

Net Loss: Net loss for the fourth quarter ended December 31, 2020, was $1.21 million, or $0.15 per share, compared to a net loss of $0.43 million, or $0.05 per share for the fourth quarter 2019. For the full year ended December 31, 2020, net loss was $2.85 million, or $0.35 per share, compared to a net loss of $5.72 million, or $0.70 per share, for the same period in 2019.

R&D Expenses: Research and development expenses were $0.23 million for the fourth quarter 2020, compared to $0.27 million for the same period in 2019. For the full year 2020, research and development expenses were $0.89 million, compared to $2.55 million for the same period in 2019. The decrease was primarily driven by a decline in grant related research expenditures and non-grant related research.

SG&A Expenses: Selling, general and administrative expenses for the fourth quarter 2020 were $1.14 million compared to $0.39 million for the fourth quarter 2019. For the full year 2020, selling, general and administrative expenses were $2.62 million, compared to $4.27 million for the same period in 2019. The decrease was primarily related to a non-recurring 2019 charge of $1.59 million of deferred IPO costs in connection with the 2018 abandoned IPO effort plus net decrease in all other selling, general and administrative expenses of $0.06 million.

Cash Position: Cash and cash equivalents were $13.95 million as of December 31, 2020.

On April 1, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that a $20 million milestone payment was triggered by the first commercial sale of Evrysdi (risdiplam) in the European Union under its License and Collaboration Agreement with Roche (Press release, PTC Therapeutics, APR 1, 2021, View Source [SID1234577524]). Approval for Evrysdi from the European Medicines Agency was received on March 30 for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older.

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"We are happy to see the rapid adoption of Evrysdi in the EU which speaks to the need for new treatments for SMA patients," said Stuart W. Peltz, Ph.D., Chief Executive Officer of PTC Therapeutics. "We are delighted that an effective at-home therapy will be available to SMA patients. We recognize that a large proportion of SMA patients in the EU are currently not receiving an approved therapy."

Roche is working closely with reimbursement and assessment bodies in European countries to enable broad and rapid access to SMA patients. Evrysdi is immediately accessible to patients in Germany and will be accessible from early April to patients in France through the cohort Temporary Authorization for Use. Evrysdi has currently been approved in 38 countries and submitted for Health Authority review in a further 33 countries.

Evrysdi is based on PTC science and is commercialized in the United States by Genentech, a member of the Roche Group. Roche led the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

About Spinal Muscular Atrophy (SMA)
Spinal muscular atrophy (SMA) is a severe, progressive neuromuscular disease that can be fatal. It affects approximately 1 in 10,000 babies and when untreated is the leading genetic cause of infant mortality. SMA is caused by a mutation of the survival motor neuron 1 (SMN1) gene, which leads to a deficiency of SMN protein. This protein is found throughout the body and is essential to the function of nerves that control muscles and movement. Without it, nerve cells cannot function correctly, leading to progressive muscle weakness over time. Depending on the type of SMA, an individual’s physical strength and their ability to walk, eat or breathe can be significantly diminished or lost.

About Evrysdi (risdiplam)
Evrysdi (risdiplam) is a survival motor neuron 2 (SMN2)-directed RNA splicing modifier designed to treat spinal muscular atrophy (SMA) caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is designed to distribute evenly to all parts of the body, including the central nervous system (CNS). Evrysdi is administered daily at home in liquid form by mouth or feeding tube. The U.S. Food and Drug Administration approved Evrysdi for the treatment of SMA for adults and children 2 months and older on August 7, 2020 and the European Medicines Agency approved Evrysdi on March 30 for the treatment of 5q SMA in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. Evrysdi is marketed in the United States by Genentech, a member of the Roche Group.

About the Evrysdi (risdiplam) Clinical Studies

FIREFISH (NCT02913482) is an open-label, two-part pivotal clinical trial in infants with Type 1 SMA. Part 1 was a dose-escalation study in 21 infants with the primary objective of assessing the safety profile of risdiplam in infants and determining the dose for Part 2. Part 2 is a pivotal, single-arm study of risdiplam in 41 infants with Type 1 SMA treated for two years followed by an open-label extension. The primary objective of Part 2 was to assess efficacy as measured by the proportion of infants sitting without support after 12 months of treatment, as assessed in the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development – Third Edition (BSID-III) (defined as sitting without support for five seconds). The study met its primary endpoint.

SUNFISH (NCT02908685) is a two part, double-blind, placebo controlled pivotal study in people aged 2 to 25 years with Types 2 or 3 SMA. Part 1 (n=51) determined the dose for the confirmatory Part 2. Part 2 (n=180) evaluated motor function using the Motor Function Measure 32 (MFM-32) scale at 12 months. MFM-32 is a validated scale used to evaluate fine and gross motor function in people with neurological disorders, including SMA. The study met its primary endpoint.

Clinical Trial Safety Data
The safety profile of Evrysdi was established across FIREFISH and SUNFISH pivotal trials. The most common adverse reactions in later-onset SMA (incidence of at least 10 percent of patients treated with Evrysdi and more frequently than control) were fever, diarrhea, and rash. The most common adverse reactions in infantile-onset SMA were similar to those observed in later-onset SMA patients. Additionally, the most common adverse reactions (incidence of at least 10 percent) were upper respiratory tract infection, pneumonia, constipation, and vomiting.

In addition to FIREFISH and SUNFISH, Evrysdi is being evaluated in a broad range of people with SMA, including in:

JEWELFISH (NCT03032172) is an open-label exploratory trial designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in people with SMA aged 6 months to 60 years who received other investigational or approved SMA therapies for at least 90 days prior to receiving Evrysdi. The study has completed recruitment (n=174).

RAINBOWFISH (NCT03779334) is an open-label, single-arm, multi-center study, investigating the efficacy, safety, pharmacokinetics, and pharmacodynamics of risdiplam in babies (~n=25), from birth to 6 weeks old (at first dose), with genetically diagnosed SMA, who are not yet presenting symptoms. The study is currently recruiting.

On April 1, 2021 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid (CBD)_medicines to improve quality of life for cancer patients, reported its financial results for the year ended December 31, 2020 and provided shareholders with an update on its accomplishments in 2021 thus far (Press release, Enveric Biosciences, APR 1, 2021, View Source [SID1234577523]).

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David Johnson, Chairman and Chief Executive Officer, said, "Since the closing of our going public transaction in late December 2020, our team has achieved several critical milestones that have positioned our Company to accelerate the execution of our vision to extend and enhance the quality of life for cancer patients in need through researching and developing novel supportive care therapies."

Mr. Johnson continued, "Our ability to strengthen our balance sheet through the closing of approximately $22.8 million in gross proceeds during the first quarter of 2021 has allowed us the opportunity to not only accelerate the research and development of our cannabinoid-based therapies, but also the optionality to evaluate a robust pipeline of strategic asset acquisitions and partnerships. During the first quarter of 2021, we launched a development collaboration and supply agreement with PureForm and shortly thereafter acquired the exclusive license to five molecules focused on pain and dermatology indications. Our team remains focused on advancing several pivotal studies throughout the remainder of 2021 in the large, unmet, supportive care market for cancer."

Corporate Updates:

Strengthened balance sheet with the closing of two registered direct offering totaling $22.8 million in gross proceeds from the closing of $10 million on January 14, 2021 and $12.8 million on February 11, 2021.

Acquired an exclusive, perpetual license from Diverse Biotech for five molecules, four of which are dermatology-focused and one that is pain-focused. As part of the agreement, Enveric will gain access to scientists and formulators to help with the research and development of these assets through pre-clinical and clinical studies to alleviate certain side effects resulting from cancer treatment.

Launched development collaboration and exclusive supply agreement with PureForm Global to support cannabinoid clinical programs aimed to treat pain and inflammation resulting from cancer treatments initially targeting supportive care indications that include radiodermatitis, chemotherapy-induced neuropathy, and glioblastoma.

Assembled a talented, world-class Executive Leadership Team, Board of Directors and Scientific Advisory Board with experience having held positions at Bristol Myers Squibb, Pfizer, Merck, Abbott, Baxter and other global healthcare and biotechnology companies. Collectively, the team has successfully led multiple therapies throughout the entire regulatory process, with substantial expertise in product development, dermatology, wound healing, oncology, intellectual property, and capital markets.
Milestones for the Remainder of 2021:

Glioblastoma Multiforme (GBM)

Q3 ’21 –We intend to seek approval from Israeli Ministry of Health (MOH), Center for Cannabis, to move forward with a Phase I/II trial
Q4 ’21 – We intend to begin enrollment of Phase I/II trial, an open label evaluation of temozolomide with clomiphene and CBD in GBM
Radiation Dermatitis

Q3 ’21 – We intend to an investigational new drug application
Q4 ’21 – We intend to initiate a Phase I/II Trial
Financial Results for the Year Ended December 31, 2020:

Net cash used in operating activities was $3,888,785 during the year ended December 31, 2020, which consisted primarily of a net loss of $6,864,676, offset by amortization of note discount of $288,631, stock-based compensation of $1,977,155, induced conversion of warrants of $802,109, amortization of intangible assets of $120,872, increases in prepaid expenses and other current assets for $636,497, and increases in accounts payable and accrued liabilities of $267,002.

Enveric’s operating expenses increased to $5,617,317, for the year ended December 31, 2020 from $2,296,534 for the year ended December 31, 2019, for an increase of $3,320,783, or 145%. This change was primarily driven by an increase in general and administrative fees of $3,146,700 and an increase in research and development costs of $174,083.

Net cash provided by financing activities was $5,531,270 during the year ended December 31, 2020. Cash as of December 31, 2020 totaled $1,578,460 and the Company currently has no debt.

Subsequent to December 31, 2020, the Company completed two registered direct offerings for gross proceeds of $22.8 million. On March 10, 2021, the Company also received $3,267,245 from the exercise of warrants to purchase 851,099 shares of common stock.

As of March 29, 2021, the Company had 19,450,507 shares of common stock outstanding.

On April 1, 2021 Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for futibatinib (TAS-120), a covalently-binding FGFR inhibitor, for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions (Press release, Taiho, APR 1, 2021, View Source [SID1234577522]). Futibatinib is an investigational therapy and has not been approved by any regulatory authority for use in patients.

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"Patients living with locally advanced and metastatic cholangiocarcinoma, or bile duct cancer, currently have a poor prognosis,1,2 particularly since there is no standard treatment after the failure of first-line chemotherapy3," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "We are pleased that the FDA has recognized the potential benefit of futibatinib in previously treated CCA patients. We look forward to continued dialogue with FDA and other Health Authorities as we work toward global availability of futibatinib for cholangiocarcinoma patients."

The decision by FDA to grant this designation is based on efficacy and safety results from the Phase 2 FOENIX-CCA2 study, which will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, taking place April 9-14, 2021.

"We are very pleased with the designation of futibatinib as a breakthrough therapy by the FDA," said Teruhiro Utsugi, Ph.D., Senior Managing Director at Taiho. "We will continue to advance our research and development efforts to deliver futibatinib, discovered in our research center, as one of the agents which may benefit cholangiocarcinoma patients around the world awaiting for new treatment options."

The FDA states that Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for BTD require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

In May 2018, the FDA Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma.

About Cholangiocarcinoma
Cholangiocarcinoma (CCA), also known as bile duct cancer, is not common. About 8,000 people in the U.S. are diagnosed with CCA each year.4 This includes both intrahepatic (inside the liver) and extrahepatic (outside the liver) cancers. CCA can occur at younger ages, but it is seen mainly in older people. The average age of people in the U.S. diagnosed with cancer of the intrahepatic bile ducts is 70, and for cancer of the extrahepatic bile ducts it is 72.4 The five-year survival rate of intrahepatic CCA (all SEER stages combined) is 9%.1

The main treatment for CCA is surgery. Radiation therapy and chemotherapy may be used if the cancer cannot be entirely removed with surgery and in cases where the edges of the tissues removed at the operation show cancer cells (also called a positive margin). Both stage III and stage IV cancers cannot be completely removed surgically. Currently, standard treatment options are limited to radiation, palliative therapy, liver transplantation, surgery, chemotherapy and interventional radiology.2

About Futibatinib (TAS-120)
Futibatinib (TAS-120) is an investigational, oral, potent, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.

On April 1, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of COPIKTRA as monotherapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies and follicular lymphoma (FL) that is refractory to at least two prior systemic therapies (Press release, Secura Bio, APR 1, 2021, View Source [SID1234577521]).

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CLL and FL are slowly progressing, incurable blood cancers that can lead to life-threatening complications such as anemia, serious infections and bone marrow failure. COPIKTRA is an oral dual inhibitor of the PI3K-delta and gamma pathways, which are involved in the proliferation, growth, and migration of malignant cells and are thought to play a role in the formation and maintenance of a supportive tumor microenvironment.

"Today’s positive opinion from the CHMP is an important step on the path toward authorization in Europe for COPIKTRA, which is expected to improve overall response rates in patients suffering from relapsed and/or refractory CLL and FL, who currently have limited treatment options. Assuming approval, COPIKTRA will provide patients and physicians across much of Europe with a treatment option that works differently from other available therapies for these incurable diseases," said Dr. David Cohan, Chief Medical Officer of Secura Bio.

The EMA summary of opinion stated "The benefits of COPIKTRA are that it prolongs the survival time without any progression of the disease as compared to ofatumumab in patients with CLL who have received 2 or more prior lines of treatment and induces tumour responses in patients with FL who have received 2 or more prior treatments. The most common side effects are respiratory tract infections, neutropenia, anaemia, thrombocytopenia, headache, dyspnoea, cough, decreased appetite diarrhoea/colitis, nausea, vomiting, abdominal pain, constipation, rash, musculoskeletal pain, arthralgia, pyrexia, fatigue and increased transaminases."

"With the expected approval of COPIKTRA in the European Union, Secura Bio will have two meaningful oncology drugs with novel modes of action. Our corporate goal is to expand our portfolio of indications worldwide, for the treatment of challenging hematologic and solid malignancies in patients with important unmet needs." said Joseph M. Limber, President and CEO of Secura Bio.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) is a cancer that affects lymphocytes with most of the cancer cells located in the bloodstream and/or the bone marrow, although the lymph nodes and spleen are often involved. The symptoms of CLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL will live for years without symptoms. There are approximately 250,000 patients in the EU affected by CLL, with nearly 25,000 new diagnoses expected this year alone. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to current agents, or are unable to tolerate treatment, generating significant unmet medical needs. The potential of effective new oral agents, particularly those that can be used as monotherapies in the community setting, offer hope in the treatment of patients with CLL.

About Follicular Lymphoma

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a "B-cell lymphoma." FL accounts for 20 to 30 percent of all NHL cases affecting more than 180,000 people in the EU, with more than 16,500, newly diagnosed cases expected this year. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin; as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at the time of diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients often living for many years following diagnosis with this form of lymphoma. New oral agents that can be added to the community hematologist’s/oncologist’s s armamentarium, particularly monotherapies, may offer significant benefit in the treatment of patients with FL.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies, and has accelerated approval for refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status in the United States, and is being investigated in combination with other agents through investigator-sponsored studies. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full prescribing information for complete boxed warning

Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate; continued approval may be contingent upon confirmatory trials.
WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS