February 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff
South San Francisco, Calif.-based Genentech announced Feb. 1, 2015 that it had been granted a second Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its cancer therapy MPDL3280A (anti-PDL1).
The designation was for the treatment of individuals with Programmed Death-Ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) that has progressed despite platinum-based chemotherapy. Another factor is appropriateness as a targeted therapy for patients with an EGFR mutation-positive or ALK-positive tumor.
“Lung cancer is the leading cause of cancer death globally, and we are pleased the FDA has granted breakthrough designation for MPDL3280A in non-small cell lung cancer,” said Sandra Horning, Genentech’s chief medical officer and head of Global Product Development in a statement. “We are committed to personalized healthcare, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines.”
Genentech recently completed a strategic agreement with Cambridge, Mass.-based Constellation Pharmaceuticals, Inc. to launch an epigenetics and chromatin biology collaboration. The company chose three targets for exclusive development and made a milestones and royalties payment deal with Constellation.
There has been some speculation that Genentech would acquire Constellation as part of the deal, but so far no news has developed. “Genentech will either acquire us or not,” said Keith Dionne, chief executive of Constellation in a statement. “What we’re planning with this reorganization is our independent future path if Genentech does not.”
The company also recently inked an agreement with genetics-testing startup 23andMe to identify new treatments for Parkinson’s disease. As part of that deal, Genentech will sequence the whole genomes of approximately 3,000 people diagnosed with Parkinson’s disease that are in 23andMe’s database. Once sequenced, they will try to identify new therapeutic targets. The deal is reportedly for $10 million upfront and $50 million in potential milestone payments.
Meanwhile, Genentech is moving ahead on MPDL3280A studies. Breakthrough Therapy Designation is developed to expedite the creation and review of drugs for serious diseases and provide access for patients through speedier FDA approval. It is a fairly new designation, with the FDA granting its first for MPDL3280A in metastatic bladder cancer in 2014.
MPDL3280A is currently involved in ongoing pivotal studies for lung and bladder cancer. Genentech has plans to begin Phase III studies in other tumor types sometime this year.
