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Pleural effusion, hemodynamically significant pericardial effusions requiring intervention, convulsions, rhabdomyolysis, Stevens-Johnson Syndrome, complex regional pain syndrome and extravasations have been reported during postmarketing use.
About Pfizer Oncology
Live vaccinations and close contact with those who received live vaccines should be avoided.
U.S. Food And Drug Administration Approves Pfizer's INLYTA(R) (axitinib) For Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC_ hypertension treatment,Welcome, $UserDisplayName
(6) INLYTA [Package Insert]. New York, NY: Pfizer, Inc. 2012.
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TORISEL may cause fetal harm. Patients and their partners should be advised to avoid pregnancy throughout treatment and for 3 months after TORISEL therapy has stopped.
DISCLOSURE NOTICE: The information contained in this release is as of January 27, 2012. The Company assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments.
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First Treatment to Demonstrate Superior Benefit in a Phase 3 Study Compared with Another Targeted Agent in Advanced RCC
NEW YORK, Jan 27, 2012 (BUSINESS WIRE) --Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved INLYTA(R) (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC) after ilure of one prior systemic therapy. The approval is based on data from the Phase 3 AXIS trial, which demonstrated that INLYTA significantly extended progression free survival (PFS) [HR=0.67, 0.54-0.81, P
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This release contains forward-looking information about certain potential additional indications for axitinib, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and develophypertension treatmentment; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for such additional indications, as well as their decisions regarding labeling and other matters that could affect their availability or commercial potential; and competitive developments.
Cases of tal bowel perforation occurred with TORISEL. These patients presented with fever, abdominal pain, metabolic acidosis, bloody stools, diarrhea, and/or acute abdomen.
Elderly patients may be more likely to experience certain adverse reactions including diarrhea, edema and pneumonia.
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Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide.
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Patients with central nervous system tumors (primary CNS tumor or metastases) and/or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (including tal outcomes) while receiving TORISEL.
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(7) Hicklin DJ, Ellis LM. Role of VEGF in Tumor Growth and Angiogenesis. JCO. 2007;23:1011-1027.
Avoid St. Johns Wort which may decrease TORISEL plasma concentrations, and grapefruit juice which may increase plasma concentrations of the major metabolite of TORISEL.
Cases of interstitial lung disease, some resulting in death, have occurred. Some patients were asymptomatic or had minimal symptoms. Patients should undergo baseline radiography prior to TORISEL therapy and periodically thereafter, even in the absence of clinical respiratory symptoms. Follow patients closely and, if clinically significant respiratory symptoms develop, consider withholding TORISEL until recovery of symptoms and radiographic improvement of pneumonitis findings. Some patients required TORISEL discontinuation and/or treatment with corticosteroids and/or antibiotics.
1.5 x ULN and should be used with caution when treating patients with mild hepatic impairment (bilirubin >1 -- 1.5 x ULN or AST >ULN but bilirubin less-than or equal to ULN). If TORISEL must be given to patients with mild hepatic impairment, reduce the dose of TORISEL to 15 mg/week. In a phase 1 study, the overall frequency of greater-than or equal to grade 3 adverse reactions and deaths, including deaths due to progressive disease, was greater in patients with baseline bilirubin >1.5 x ULN.
Serum glucose, serum cholesterol, and triglycerides should be tested before and during TORISEL treatment. TORISEL is likely to result in hyperglycemia and hyperlipemia. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy and/or lipid-lowering agents, respectively.
Hypersensitivity/infusion reactions, including flushing, chest pain, dyspnea, hypotension, apnea, loss of consciousness, hypersensitivity and anaphylaxis, may occur very early in the first infusion or with subsequent infusions. Pretreat with an H1 antihistamine. TORISEL infusion should be interrupted in patients with infusion reactions and appropriate therapy given.
Cases of rapidly progressive and sometimes tal acute renal ilure not clearly related to disease progression occurred in patients who received TORISEL.
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The most common (incidence greater-than or equal to 30%) adverse reactions observed with TORISEL are: rash (47%), asthenia (51%), mucositis (41%), nausea (37%), edema (35%), and anorexia (32%). The most common laboratory abnormalities (incidence greater-than or equal to 30%) are anemia (94%), hyperglycemia (89%), hyperlipemia (87%), hypertriglyceridemia (83%), elevated alkaline phosphatase (68%), elevated serum creatinine (57%), lymphopenia (53%), hypophosphatemia (49%), thrombocytopenia (40%), elevated AST (38%), and leukopenia (32%).
As a leader in the treatment of advanced RCC, Pfizer Oncology is dedicated to offering multiple treatments and investigating new agents in different populations and stages of disease.
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TORISEL may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections.
U.S. Food And Drug Administration Approves Pfizers INLYTA(R) (axitinib) For Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC)
For more information on TORISEL, including full prescribing information for TORISEL (temsirolimus), please visit .
The combination of TORISEL and sunitinib resulted in dose-limiting toxicity (Grade 3/4 erythematous maculopapular rash, and gout/cellulitis requiring hospitalization).
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(2) American Cancer Society. Detailed Guide: Kidney Cancer. (Adult) -- Renal Cell Carcinoma. Available at: . Acessed May 4, 2011.
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(4) Pfizer data on file.
(10) ClinicalTrials.gov. Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer. Available at: . Accessed July 12, 2011.
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Strong inducers of CYP3A4/5 (eg, dexamethasone, rimpin) and strong inhibitors of CYP3A4 (eg, ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended.
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(9) ClinicalTrials.gov. Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer. Available at: . Accessed October 13, 2011.
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SOURCE: Pfizer Inc.
(8) ClinicalTrials.gov. Axitinib (Ag 013736) As Second Line Therapy for Metastatic Renal Cell Cancer. Available at: . Accessed July 12, 2011.
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Due to abnormal wound healing, use TORISEL with caution in the perioperative period.
(11) Clinical Trials.gov. Axitinib For The Treatment of Advanced Hepatocellular Carcinoma. Available at: . Accessed July 12, 2011.
(3) D. Y. Heng et al. Ann. Onc., November 5, 2011; (2011) mdr533v1.
(5) Pfizer data on file.
(1) Lynch, C. F., West, M. M., Davila, J. A., & Platz, C. E. (n.d.). SEER Survival Monograph: Chapter 24 Cancers of the Kidney and Renal Pelvis. National Cancer Institute. Available at: . Accessed Jan. 3, 2012.
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Pfizer Inc. Media Contact: Jenifer Antonacci, 610-427-0369 or Investors Contact: Charles Triano, 212-733-3901
A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.
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Most common grades 3/4 adverse events and laboratory abnormalities included asthenia (11%), dyspnea (9%), hemoglobin decreased (20%), lymphocytes decreased (16%), glucose increased (16%), phosphorus decreased (18%), and triglycerides increased (44%).
