Genentech braces for blockbuster FDA decision on pertuzumab for breast cancer

By the end of day tomorrow we should know whether Genentech's latest blockbuster hopeful on the cancer front has earned an FDA approval or faces a delay. The agency has a Friday PDUFA deadline to hit after providing pertuzumab a priority review on some significant data on the drug's ability to stall breast cancer when combined with Herceptin (trastuzumab).

Vontobel analysts have projected peak potential sales of pertuzumab at $1.8 billion, though Genentech has yet to publicly discuss what it will charge for the treatment.

In an article on Xconomy today, Luke Timmerman offers an elegant description of the way researchers zeroed in on a new approach to breast cancer, proving that adding a separate antibody with a fresh target on HER2 molecules could add months to a patient's progression-free survival rate. That came after the drug offered only modest benefits as a standalone therapy.

We won't see overall survival rate data until next year, but Genentech--a subsidiary of Roche ($RHHBY)--has been confident that it can succeed with what it already knows. Genentech has also been burnishing its reputation as a leader in the field of armed antibodies. Its T-DM1 therapy provided a fresh example at ASCO this year of how an antibody-drug conjugate can work against cancer. And Genentech's Dietmar Berger told FierceBiotech at the meeting that the company is prepping for a combination study of T-DM1 and pertuzumab.

As Xconomy notes, though, there's some fretting going on about the cost of these new combos. Herceptin isn't cheap. And adding another expensive treatment to the package may appeal to patients but cause some financial heartburn among the payer community.

- here's the article from Xconomy

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