Genentech pitches Avastin compromise to FDA

As the clock winds down on Avastin's fate as a breast cancer treatment in U.S., Genentech has put forth a compromise. The U.S.-based Roche unit proposes a "middle-ground" solution: Keep the indication specifically for breast cancer patients who need it most. In other words, patients with the biggest tumors, the most metastases, the most aggressive cancer--and the fewest treatment options.

The company's pitch comes after the FDA moved to pull the indication--and after two days' worth of appeal hearings, when an FDA advisory panel sided with the agency. "Two facts cannot be disputed in the wake of the hearing," Genentech wrote to the agency (as quoted by Medscape). "The approved treatment options for patients with metastatic disease are extremely limited, particularly for patients who face aggressive disease, and Avastin ... indisputably has an effect on this form of breast cancer."

So, Genentech offers new labeling for FDA's consideration. Avastin would keep its indication for metastatic breast cancer, but the treatment would be restricted to women with aggressive disease and few treatment options. For instance, women with so-called triple-negative disease. The label would also restrict Avastin to its combination with paclitaxel (which has the best data, Medscape writes) and would offer info about "differing effects" of other combinations (which have not-as-good trial data). The company is also offering to come up with a risk-management plan.

The proposal just might give the FDA a way out; no need to point out that the move against Avastin has put the agency in the hot seat. Patients, politicians and some doctors are spitting mad. Others back the FDA's vow to make a dry, scientific decision. Complicating matters is that European regulators not only affirmed Avastin for use with paclitaxel, but broadened the approval to cover use with Xeloda, too. FDA Commissioner Margaret Hamburg is due to decide next month.

- see the story from Medscape
- get more from the San Francisco Business Times

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