publication date: Jun. 27, 2014


By Paul Goldberg and Tessa Vellek

Some of the questions that landed the AstraZeneca drug Olaparib (lynparza) before the FDA Oncologic Drugs Advisory Committee were classic:

• How much progression-free survival is enough?

• Can you make use of post-hoc analysis to identify a cohort in which the drug appears to be most effective?

Two big questions in their own right, but in the case of Olaparib, these questions were even more important because of the setting. Olaparib is intended as maintenance for relapsed ovarian cancer, where the standard of care is no cancer drugs at all.

That being the case, the application posed two even more intriguing questions:

• How much toxicity is too much for a drug in a setting where the accepted alternative is not to treat?

• And—in ovarian cancer—is PFS an acceptable endpoint in the maintenance setting? One of the maintenance therapies on the market—Eli Lilly’s Alimta (pemetrexed for injection)—was approved based on overall survival in the treatment of advanced nonsquamous non-small cell lung cancer.

Finally the question of accelerated approval loomed large.

ODAC was asked to decide on accelerated approval before the confirmatory trial was fully accrued. Would patients be willing to accept randomization to the standard of care—nothing—after a maintenance therapy becomes available?

The committee undid this Gordian Knot of questions by recommending against accelerated approval in an 11-2 vote at its hearing June 25. For the future, the group discussed the question of … Continue reading 40-26 ODAC Clarifies Standards for Maintenance In Ovarian Cancer; Nixes Olaparib in 11-2 Vote

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