Genentech Plans Avastin Breast Cancer Resubmission In August
This article was originally published in The Pink Sheet Daily
Executive Summary
Company expects a six-month review for the supplemental claim, setting early 2008 for potential FDA approval.
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Genentech plans to resubmit an sBLA for Avastin (bevacizumab) for the treatment of metastatic breast cancer in August, which could result in an early 2008 approval for the indication, the company announced during its second quarter sales and earnings release July 11. "We expect that the independent radiologic review will be in line with the investigator analysis," Product Development President Susan Desmond-Hellmann stated. Genentech had been seeking approval of Avastin for the treatment of women with metastatic breast cancer in combination with the standard chemotherapy paclitaxel last year, but received a "complete response" letter to its sBLA from FDA in September requesting an independent review of patients' scans for progression-free survival (1 (Also see "Genentech To Resubmit Avastin sBLA In Mid-2007" - Pink Sheet, 11 Sep, 2006.)). The resubmission will be based on data from the original E2100 study, showing that women with metastatic breast cancer lived twice as long without their cancer progressing if treated with Avastin plus paclitaxel compared to paclitaxel alone. The trial served as the basis for the March European approval of Roche's marketing authorization application of Avastin in the breast cancer setting (2 (Also see "Roche Considers Pricing Flexibility For Avastin In Europe" - Pink Sheet, 18 Apr, 2007.)). Genentech said it anticipates a six-month review of the sBLA, which would be in line with FDA's typical handling of resubmissions. However, the company noted it has not completed discussions with FDA on the timing. "Our next milestone really is to submit the data, and FDA will let us know the timeline post-submission of the data in August," Desmond-Hellmann said. "Based on August, we would expect an approval in the first half of next year, whether it's a six-month or 10-month review." Genentech also plans to evaluate Avastin in the adjuvant breast cancer study. According to Desmond-Hellman, the company is on track to present a pilot study of Avastin in the HER2-negative adjuvant setting at the San Antonio Breast Cancer Symposium, which is scheduled for December. "We're on the brink of initiating trials with Avastin, the Phase III definitive trials in breast cancer," she said. "The first adjuvant study that was started up in last quarter was in lung, and soon to follow will be the breast in HER2-negative. There will subsequently be a HER2-positive study that's planned as well." Avastin is already approved for first or second-line treatment of patients with metastatic colorectal cancer and for recurrent or metastatic non-squamous, non-small cell lung cancer. Genentech also plans to seek an indication for Avastin for first-line renal cell cancer in combination with interferon following positive Phase III study results presented by Roche at the American Society of Clinical Oncology meeting in June (3 (Also see "Avastin Makes Headway Into Renal Cell Carcinoma" - Pink Sheet, 4 Jun, 2007.)). During the second-quarter call, Genentech also released positive data on the secondary endpoints of its own study evaluating Avastin in RCC, showing results similar to that seen in Roche's AVOREN study, the company reported. Sales of Avastin increased 33 percent in the second quarter to $564 million, the company said. Sales of Rituxan (rituximab) increased 11 percent to $582 million. Total U.S. product sales increased 25 percent to $2.15 billion. Non-GAAP net income increased 39 percent to $834 million in the quarter. -Jessica Merrill ([email protected]) |