Genentech Submits NDA For Skin Cancer Med Cobimetinib

Published: Dec 16, 2014

Genentech Submits NDA For Skin Cancer Med Cobimetinib
December 15, 2014
By Krystle Vemes, BioSpace.com Breaking News Staff

Roche group member Genentech announced today that it has submitted a New Drug Application for cobimetinib, in combination with vemurafenib, for the treatment of an advanced form of melanoma. Vemurafenib, also known as Zelboraf on the market, would work in conjunction with cobimetinib to treat the BRAF V600 mutation-positive version of melanoma in patients.

“In the past several years we have made significant progress in treating advanced melanoma, but it remains a serious and difficult to treat cancer that affects more people each year,” said Sandra Horning, chief medical officer and head of Global Product Development at Genentech. “We look forward to working with the FDA as they review the NDA and hope the combination of cobimetinib and Zelboraf will soon become a new option for people with BRAF mutation-positive advanced melanoma.”

The Implications of a Phase 3 Study
The NDA submission is based on a recent coBRIM Phase 3 study, which showed that people who received cobimetinib in conjunction with vemurafenib were able to live significantly longer without their disease becoming worse. This was in comparison to those who received vemurafenib alone, without cobimetinib.

Genentech conducted the phase 3 trial with 495 patients who have BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma. The results of the study show that there was a significant increase in the progress-free survival rate. The average PFS was 9.9 months, compared to 6.2 months when patients took vemurafenib alone. Adverse effects were diarrhea, nausea, rash and photosensitivity.

The results of the study were shared during the Presidential Symposium at the European Society for Medical Oncology 2014 Congress gathering.

The Discovery of Cobimetinib
Exelixis, Inc., a biopharmaceutical company aimed at developing small molecule therapies for cancer treatment, is responsible for discovering cobimetinib internally. It also advanced the compound to investigational new drug status.

In 2006, Exelixis entered a co-development agreement with Genentech for cobimetinib. As a result, Exelixis received upfront and milestone payments, and the company remained responsible for the development of cobimetinib through the maximum tolerated dose in phase 1.

In 2013, Exelixis exercised its option to promote cobimetinib, if approved, within the U.S. The company is also entitled to an equal share of profits and losses, which will decrease as sales increase. Additionally, Exelixis remains eligible to receive royalties on the sales of products outside of the U.S.

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