British Journal of Cancer: Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation agents

On July 30, 2024 InnoCare reported that British Journal of Cancer, part of leading science journal Nature, recently published a paper entitled "Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation agents" (Press release, InnoCare Pharma, JUL 30, 2024, View Source [SID1234645185]). The journal concluded that zurletrectinib is a novel, highly potent next-generation TRK inhibitor with higher in vivo brain penetration and stronger intracranial activity than other next-generation agents.

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The paper pointed out that zurletrectinib displayed strong potency against TRKA, TRKB, and TRKC WT kinases, as well as acquired resistance mutations TRKA G595R and TRKA G667C. Zurletrectinib was more active than other FDA approved or clinically tested first generation (larotrectinib) and next-generation (selitrectinib and repotrectinib) TRK inhibitors against most TRK inhibitor resistance mutations. Similarly, zurletrectinib (1 mg/kg BID) inhibited tumor growth in xenograft models derived from NTRK fusion-positive cells at a dose 30 times lower when compared to selitrectinib.

The paper further demonstrated that, in a central nervous system (CNS) penetrant pharmacokinetic study in SD rats, zurletrectinib showed improved ability to penetrate the blood-brain barrier, reaching the brain more effectively than selitrectinib and repotrectinib. Zurletrectinib’s increased brain penetration was also translated into improved antitumor activity. In an orthotopic mouse glioma xenograft model carrying the TRKA G598R/G670A resistance mutation, zurletrectinib (15 mg/kg) significantly improved the survival of mice harboring orthotopic NTRK fusion-positive, TRK-mutant gliomas (median survival = 41.5, 66.5, and 104 days for selitrectinib, repotrectinib, and zurletrectinib respectively; P < 0.05), showing superior efficacy compared to repotrectinib (15 mg/kg) and selitrectinib (30 mg/kg) (P=0.0384 and 0.0022, respectively), with an excellent safety profile.

The corresponding authors of the paper are Dr. Alexander Drilon, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA, and Dr. Emiliano Cocco, Department of Biochemistry and Molecular Biology, University of Miami, Miller School of Medicine, FL, USA. The first author is Paolo Roa, Department of Biochemistry and Molecular Biology, University of Miami, Miller School of Medicine, FL, USA. Full text can be found in View Source

InnoCare is accelerating the registrational trial of zurletrectinib in China. The clinical study with zurletrectinib has covered NTRK fusion adult patients, adolescent patients and pediatric patients. Zurletrectinib has demonstrated good efficacy and safety profile, and overcome acquired resistance to the first generation TRK inhibitors, bringing benefit to patients who failed prior TRKi therapy.

Takeda Announces First Quarter FY2024 Results – Strong Performance by Growth & Launch Products; Advancements in Promising Late-Stage Pipeline

On July 30, 2024 Takeda (TOKYO:4502/NYSE:TAK) reported earnings results for the first quarter of fiscal year 2024 (period ended June 30, 2024), with continued momentum in its Growth & Launch Products driving Core growth at CER and more than offsetting revenue impact resulting from significant losses of exclusivity that occurred in the previous fiscal year (Press release, Takeda, JUL 30, 2024, View Source;Strong-Performance-by-Growth-Launch-Products-Advancements-in-Promising-Late-Stage-Pipeline [SID1234645184]).

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The strong performance of Takeda’s Growth and Launch Product portfolio, which grew 17.8% at CER and represented 46% of total revenue, supports the company’s outlook for a return to sustainable revenue and profit growth in the near term and its ability to deliver life-transforming treatments and vaccines.

In addition, positive Phase 2b data presented in June for TAK-861 in narcolepsy type 1 and for mezagitamab (TAK-079) in immune thrombocytopenia (ITP), a rare immune-mediated bleeding disorder, underscore the promise of Takeda’s late-stage pipeline and the potential for strong revenue growth into the next decade and beyond.

Takeda chief financial officer, Milano Furuta, commented:
"Takeda has delivered a positive first quarter performance, with Growth and Launch Products driving overall revenue growth. Our results reflect strong commercial execution, with new launches, geographic expansion and lifecycle management enabling us to reach more patients and communities around the world.

"First quarter Core Operating Profit benefitted from this strong Growth and Launch Product performance, as well as from phasing of R&D investment, reduction in other OPEX and milder than anticipated VYVANSE generic erosion in the U.S.

"There is no change to our full-year FY2024 outlook announced in May. We expect the impact of generic erosion to accelerate in coming quarters and the phasing of our R&D investment will focus on the second half of the year due to the planned initiation of multiple Phase 3 programs. Foreign exchange has been a tailwind for revenue performance in the first quarter and we see potential upside to our revenue forecast if current foreign exchange rates continue."

FINANCIAL HIGHLIGHTS for FY2024 Q1 Ended June 30, 2024

(Billion yen, except percentages and per share amounts)

FY2024 Q1

FY2023 Q1

vs. PRIOR YEAR

(Actual % change)

Revenue

1,208.0

1,058.6

+14.1%

Operating Profit

166.3

168.6

-1.3%

Net Profit

95.2

89.4

+6.5%

EPS (Yen)

61

58

+5.6%

Operating Cash Flow

170.3

92.4

+84.3%

Adjusted Free Cash
Flow (Non-IFRS)

23.7

-207.5

N/A

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

FY2024 Q1

FY2023 Q1

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change)

Revenue

1,208.0

1,058.6

+14.1%

+2.1%

Operating Profit

382.3

326.3

+17.1%

+4.5%

Margin

31.6%

30.8%

+0.8pp

Net Profit

276.8

233.4

+18.6%

+3.9%

EPS (Yen)

176

150

+17.5%

+2.9%

FY2024 Outlook (unchanged from May 2024)

(Billion yen, except percentages and per share amounts)

FY2024
FORECAST

FY2024
MANAGEMENT GUIDANCE
Core Change at CER
(Non-IFRS)

Revenue

4,350.0

Core Revenue (Non-IFRS)

4,350.0

Flat to slightly declining

Operating Profit

225.0

Core Operating Profit (Non-IFRS)

1,000.0

Approximately 10% decline

Net Profit

58.0

EPS (Yen)

37

Core EPS (Yen) (Non-IFRS)

431

Mid-10s% decline

Adjusted Free Cash Flow (Non-IFRS)

350.0 – 450.0

Annual Dividend per Share (Yen)

196

Additional Information About Takeda’s FY2024 Q1 Results
For more details about Takeda’s FY2024 Q1 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2024 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2024 Q1 investor presentation (available at View Source)

Synthetica Pioneering Closes a Series A Funding Round to Support Development of Oncolytic Bacterial Therapy for Solid Tumors

On July 30, 2024 Shenzhen Synthetica Pioneering Co., Ltd. (Synthetica), a biotech startup specializing in synthetic biology for engineering novel living bacterial therapeutics, reported that it has recently closed a Series A funding round, led by Boehringer Ingelheim Venture Fund and Temasek, with additional participation from Lenovo Capital, Fosun Health Capital and ATLATL Summer Fund (Press release, Shenzhen Synthetica Pioneering, JUL 30, 2024, View Source [SID1234645183]). The funding will be used to fast-track Synthetica’s oncolytic bacterial pipelines into clinical trials.

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Headquartered in Shenzhen, China, Synthetica is a biotech company founded in 2023, specializing in genetic circuit engineering and precise control of genes and payloads to treat various diseases. Synthetica is currently focused on developing oncolytic bacterial therapies for treating solid tumors. With a deep understanding of biological mechanisms and advanced synthetic biology techniques, Synthetica is aiming to create innovative bacterial treatments that are safe, effective, versatile, and minimally invasive to fight cancer.

Synthetica’s CEO, Yingke He stated: "Securing this funding marks a pivotal moment for our young company as we advance the frontier of cancer treatment. Our innovative synthetic biology approach to developing oncolytic bacteria offers new hope for more effective and targeted therapies. We extend our heartfelt thanks to our technology contributors and financial investors for their trust and support. Together we will drive this breakthrough science forward, and make significant advancements in the fight against cancer, bringing us closer to transforming patients’ lives worldwide."

Dr. Mia Hu, Investment Director, Boehringer Ingelheim Venture Fund, commented: "Boehringer Ingelheim Venture Fund (BIVF) is committed to invest in innovative therapeutics that address unmet patient needs. Oncolytic bacterial therapy remains a key strategic focus for the Boehringer Ingelheim Venture Fund. The Synthetica team, with its years of expertise in quantitative synthetic biology, is pioneering the development of innovative bacterial therapies for various indications. We are thrilled to support Synthetica in their ongoing efforts to advance next-generation bacterial therapies for the treatment of solid tumors, with the ultimate goal of transforming the lives of more people living with cancer."

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible

On July 30, 2024 Johnson & Johnson (NYSE:JNJ) reported that the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT) (Press release, Johnson & Johnson, JUL 30, 2024, View Source [SID1234645182]). Patients will have the opportunity to receive this DARZALEX FASPRO-based quadruplet therapy at initial diagnosis, providing them with a new treatment that may significantly improve outcomes.

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This approval is supported by data from the Phase 3 PERSEUS study evaluating DARZALEX FASPRO in a regimen that included D-VRd induction and consolidation therapy compared to bortezomib, lenalidomide and dexamethasone (VRd) during induction and consolidation in patients with NDMM eligible for ASCT.1 Following consolidation, patients received an investigational treatment regimen for maintenance that included DARZALEX FASPRO in combination with lenalidomide or lenalidomide alone.1

"Multiple myeloma has a highly varied clinical course among patients and in each individual patient, and there is a continued need for innovation and therapies that employ different targets and combinations to provide patients with treatment options at diagnosis and throughout the course of their disease," said Amrita Y. Krishnan, M.D., Professor and Director of the Judy and Bernard Briskin Multiple Myeloma Center, City of Hope.* "The efficacy data supporting this new quadruplet regimen, combined with its established safety and tolerability profile, provide compelling evidence that adding D-VRd upon initial diagnosis as compared to VRd can deepen responses and prolong remissions in the context of autologous stem cell transplantation."

Findings from the PERSEUS study demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with D-VRd reducing the risk of disease progression or death by 60 percent compared to VRd (HR [95% CI]: 0.40 [0.29, 0.57]; p-value < 0.0001).1 Treatment with D-VRd induction and consolidation resulted in deeper responses at the end of consolidation compared to VRd: minimal residual disease (MRD) negativity rates of 57.5 percent vs. 32.5 percent, and MRD-negativity rates in patients with complete response (CR) or better of 76.6 percent vs. 58.5 percent, respectively.1

"This latest indication for DARZALEX FASPRO-based quadruplet therapy demonstrated a clinically significant reduction in disease progression or death during first-line treatment when patients are likely to experience their deepest responses," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson. "Today’s approval embodies our commitment to setting new standards of care for patients newly diagnosed with multiple myeloma who are transplant eligible."

The overall safety profile of D-VRd was consistent with the known safety profiles for DARZALEX FASPRO and VRd.1 The most common adverse reactions (≥20%) in patients with multiple myeloma who received D-VRd are peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.1

About the PERSEUS Study
The PERSEUS study is being conducted in collaboration with the European Myeloma Network as the sponsor. PERSEUS is an ongoing, randomized, open-label, Phase 3 study comparing the efficacy and safety of D-VRd during induction and consolidation versus VRd during induction and consolidation in patients with NDMM eligible for ASCT. Following consolidation, patients received an investigational treatment regimen for maintenance that included DARZALEX FASPRO in combination with lenalidomide or lenalidomide alone. The trial was not designed to isolate the effect of DARZALEX FASPRO in the maintenance phase of treatment. The efficacy of DARZALEX FASPRO in combination with lenalidomide for maintenance has not been established. The primary endpoint is PFS, and secondary endpoints include overall CR or better rate, and overall MRD-negativity (in patients with CR or better). The median age is 61.0 (range, 32-70) years for patients in the D-VRd arm and 59.0 (range, 31-70) years for patients in the VRd arm.2 The study is being conducted in 14 countries in Europe and Australia.

About Multiple Myeloma
Multiple myeloma is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.3 In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.4 Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.5 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 will die from the disease.6 People with multiple myeloma have a 5-year survival rate of 59.8 percent.6 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.7,8

About DARZALEX FASPRO
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.1 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.

For more information, visit View Source

DARZALEX FASPRO INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:

In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant
In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI)
In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent
IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS 
DARZALEX FASPRO is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation. 

WARNINGS AND PRECAUTIONS 

Hypersensitivity and Other Administration Reactions 
Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO. 

Systemic Reactions 
In a pooled safety population of 1249 patients with multiple myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 0.7%, Grade 4: 0.1%). Systemic administration-related reactions occurred in 7% of patients with the first injection, 0.2% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 2.9 hours (range: 5 minutes to 3.5 days). Of the 165 systemic administration-related reactions that occurred in 93 patients, 144 (87%) occurred on the day of DARZALEX FASPRO administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO.

Local Reactions 
In this pooled safety population, injection-site reactions occurred in 7% of patients, including Grade 2 reactions in 0.8%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO. Monitor for local reactions and consider symptomatic management.

Neutropenia
Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO, higher rates of Grade 3-4 neutropenia were observed.

Thrombocytopenia 
Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Consider withholding DARZALEX FASPRO until recovery of platelets. 

Embryo-Fetal Toxicity 
Based on the mechanism of action, DARZALEX FASPRO can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO and for 3 months after the last dose. 

The combination of DARZALEX FASPRO with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy. 

Interference With Serological Testing 
Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type are not impacted. 

Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO. Type and screen patients prior to starting DARZALEX FASPRO. 

Interference With Determination of Complete Response 
Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO-treated patients with IgG kappa myeloma protein. 

ADVERSE REACTIONS 
In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, peripheral edema, musculoskeletal pain, and rash.

The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin. 

Please click here to read full Prescribing Information for DARZALEX FASPRO.

European Medicines Agency (EMA) Approves Bio-Thera Solutions’ BAT1706 (Avzivi®, bevacizumab), a biosimilar referencing Avastin

On July 30, 2024 Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that the EMA has approved BAT1706 (bevacizumab), a biosimilar referencing Avastin (Press release, BioThera Solutions, JUL 30, 2024, View Source [SID1234645181]). Sandoz AG and its affiliates have rights to market BAT1706 in Europe under the brand name Avzivi. BAT1706 is Bio-Thera’s second EMA approved product and Bio-Thera’s second product to receive marketing authorization from NMPA, US FDA and EMA.

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"The EMA approval of BAT1706 is another significant accomplishment for Bio-Thera as it marks Bio-Thera’s second EMA approved product," said Shengfeng Li, CEO at Bio-Thera. "As our biosimilar pipeline continues to mature, we intend to seek more biosimilar approvals, expanding patient access to important therapies."

Bio-Thera and Sandoz AG entered into a license and commercialization agreement for BAT1706 (Avzivi) in September 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Sandoz is responsible for the commercialization of Avzivi in the European Union, the United States and other countries around the world.

About BAT1706 (Avzivi, bevacizumab)

BAT1706 (Avzivi, bevacizumab) is a humanized monoclonal antibody that targets VEGF. It specifically binds to VEGF and blocks the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. The brand name for BAT1706 in the EU and the United States is Avzivi. In the Europe, Avzivi is indicated for the treatment of 1) Metastatic carcinoma of the colon or rectum, in combination with fluoropyrimidine-based chemo-therapy is indicated for treatment of adult patients, 2) Metastatic breast cancer, in combination with paclitaxel is indicated for first-line treatment of adult patients, 3) Metastatic breast cancer, in combination with capecitabine is indicated for first-line treatment of adult patients in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avzivi in combination with capecitabine. 4) Unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology, in addition to platinum-based chemotherapy is indicated for first-line treatment of adult patients, 5) Unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations, in combination with erlotinib, is indicated for first-line treatment of adult patients, 6) Advanced and/or metastatic renal cell cancer, in combination with interferon alfa-2a is indicated for first line treatment of adult patients, 7) Advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients, 8) Platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel in adult patients with first recurrence who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents, 9) Platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in adult patients who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents, 10) Persistent, recurrent, or metastatic carcinoma of the cervix, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in adult patients who cannot receive platinum therapy.