Avastin gets its chance to prove worthy for FDA

Roche is getting its day in FDA court. The company will argue for Avastin as a breast cancer treatment June 28-29. It's a special hearing requested by Roche's Genentech unit, which developed Avastin, after the FDA announced plans to pull the drug's indication for breast cancer.

It's no surprise the agency chose to give Roche its hearing. The breast cancer decision met with vocal protest from elected officials--who seized upon it to bolster claims that the government would "ration" healthcare--and from oncologists and patient groups as well. But it was also hailed by some cancer doctors and leading breast-cancer advocacy organizations. To satisfy critics, the agency has to listen to Roche's side of the story.

Since the FDA's December announcement, however, some supporters have backpedaled away from Avastin. The Susan G. Komen Foundation recommended against new prescriptions, even though Medicare promised to cover treatment for anyone who started Avastin before the FDA's final decision, even if that decision goes against the drug. Oncologists tell Bloomberg that they're not prescribing the costly Avastin as much as they once did because the side effects outweigh the benefits.

The company has already dialed back revenue projections for the drug, which once was expected to reach 9 billion Swiss francs in annual sales. But it stands by Avastin's usefulness as a breast-cancer treatment, and cancer doctors say that some women do see extraordinary results. It's just difficult to know which women will.

"We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer," Genentech's chief medical officer Hal Barron said in a statement. He called Avastin an important option for women and said it should remain FDA-approved.

- see the New York Times story
- get more from Bloomberg
- read the Reuters article

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