FDA Rejects Roche's Avastin for Breast Cancer

A FDA panel dealt a blow to Roche's multibillion-dollar cancer drug Avastin on July 20, 2010 urging US officials to revoke the medicine's approval for breast cancer after concluding studies showed insufficient benefit for patients. Members of the FDA were not convinced with Avastin benefits in advanced breast cancer. The drug did not extend patients' lives but delayed cancer growth by up to three months. That improvement was not enough to justify serious complications, panelists said. They voted 12-1 to urge the FDA to remove the breast cancer approval.

Avastin, which is given intravenously, delayed the growth of cancer by 5.5 months in the initial study. In the two later studies, the time ranged from about one month to three months. Avastin, which works by starving tumors of the blood vessels they need to grow, did not extend overall survival (OS) in any of the studies. Advanced breast cancer patients generally live about 18 to 24 months, the FDA said. The FDA usually follows panel recommendations. A decision is due by September 17, 2010.

Source: Reuters

 

FDA Approves Tasigna for Newly Diagnosed CML Patients

Following a priority review, the FDA has approved Tasigna (nilotinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. With this approval, Tasigna becomes the first new therapeutic option for newly diagnosed patients since the introduction of Glivec (imatinib), providing a major advance for patients with this blood cancer.

The US approval was based on results of the pivotal ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) Phase III clinical trial. Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes the production of cancer cells in Ph+ CML. It is also active against a broad spectrum of Bcr-Abl mutations associated with resistance to Glivec. The randomized, open-label, multicenter ENESTnd trial compared the efficacy and safety of Tasigna with Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase. It is the largest global randomized head-to-head comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients in chronic phase. Tasigna surpassed Glivec in key measures of treatment efficacy, as has been previously reported. Tasigna eliminated Bcr-Abl faster than Glivec, resulting in lower rates of cancer progression even as early as 12 months. Treatment with Tasigna led to higher rates of both major molecular response and complete cytogenetic response than with Glivec.

Source: Novartis

 

Cabazitaxel Injection Approved by FDA after Priority Review

Sanofi-aventis announced that the FDA has granted marketing authorization for Jevtana (cabazitaxel) injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC), previously treated with a docetaxel-containing treatment regimen.

Cabazitaxel, a microtubule inhibitor, in combination with prednisone was approved based on results from the Phase III TROPIC clinical study involving 755 patients with mHRPC, previously treated with a docetaxel-containing treatment regimen. The trial results demonstrated a statistically significant 30% reduction in the risk of death from mHRPC among patients taking Jevtana in combination with prednisone, compared with an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone. Investigator-assessed tumor response rates using Response Evaluation Criteria in Solid Tumors (RECIST) were 14.4% and 4.4% for cabazitaxel-treated and mitoxantrone-treated patients, respectively. Jevtana in combination with prednisone is the only FDA-approved regimen to significantly improve OS in patients previously treated with a docetaxel-based chemotherapy regimen.

Source: Sanofi-aventis

 

Pfizer Announces Voluntary Withdrawal of Mylotarg for AML from US Market

Pfizer will discontinue the commercial availability of Mylotarg (gemtuzumab ozogamicin for injection (used for the treatment of relapsed acute myeloid leukemia (AML)) in the US, based on discussions with the FDA. The company will voluntarily withdraw the new drug application (NDA) for Mylotarg, effective October 15, 2010.

The approval of single-agent Mylotarg in the US was granted under the FDA's accelerated approval regulations based on the overall response rate (ORR) in three non-comparative studies, and required the submission of additional data to confirm clinical benefit. The required post-approval study (SWOG S0106) combining chemotherapy and Mylotarg did not demonstrate improved survival compared with chemotherapy alone in patients with previously untreated AML. Additionally, among all patients evaluable for early toxicity, the fatal induction toxicity rate was significantly higher in subjects given the combination of standard induction chemotherapy and Mylotarg than in those treated with chemotherapy alone. Mylotarg was approved in the US as a single agent for patients with CD33 positive AML in first relapse, who are 60 years of age or older and are not considered candidates for other cytotoxic chemotherapy.

Source: Pfizer

 

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