On July 1, 2015 Exelixis reported yesterday Exelixis’ partner Genentech, a member of the Roche Group, informed Exelixis that, in order to accommodate its review of a supplemental data submission, the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of Genentech’s New Drug Application (NDA) for cobimetinib by the standard extension period of three months, from August 11, 2015 to November 11, 2015 (Press release, Exelixis, JUL 1, 2015, View Source;p=RssLanding&cat=news&id=2064058 [SID:1234506017]).
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FDA extended its review after Genentech submitted, at FDA request, additional data from coBRIM, the phase 3 registrational trial of cobimetinib and vemurafenib in patients with BRAF V600 mutation-positive advanced melanoma.
Exelixis discovered cobimetinib, a selective inhibitor of MEK, internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments in connection with signing the agreement and submitting the IND. Exelixis was responsible for development of cobimetinib through the determination of the maximum tolerated dose in phase 1, at which point Genentech exercised its option to further develop the compound.
In November 2013, Exelixis exercised its option to co-promote cobimetinib, if approved, in the United States. Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share equally in the U.S. marketing and commercialization costs. Exelixis is eligible to receive royalties on any sales of the product outside the United States.
About the Cobimetinib and Vemurafenib Combination
Cobimetinib is a selective inhibitor that blocks the activity of MEK, a protein kinase that is part of a key pathway (the RAS-RAF-MEK-ERK pathway) that promotes cell division and survival. This pathway is frequently activated in human cancers including melanoma, where mutation of one of its components (BRAF) causes abnormal activation in about 50% of tumors. Tumors with BRAF mutations may develop resistance and subsequently progress after treatment with a BRAF inhibitor. In preclinical melanoma models, co-treatment with a BRAF inhibitor and a MEK inhibitor may delay the emergence of resistant tumors. In addition to the combination with vemurafenib in melanoma, cobimetinib is also being investigated in combination with several investigational medicines, including an immunotherapy, in several tumor types, including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer and melanoma.