FDA grants Roche’s cancer immunotherapy Atezolizumab Priority Review

Friday, March 18, 2016

The FDA has accepted Roche’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

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FDA files Genentech’s sBLA of Xolair for pediatric allergic asthma

Wednesday, March 2, 2016

Genentech, a member of the Roche Group, has announced the FDA accepted for review the company’s supplemental Biologics License Application (sBLA) to extend the indication of Xolair (omalizumab) in allergic asthma to pediatric patients. The FDA will review Xolair in children from six through 11 years for the treatment of moderate to severe persistent asthma in those patients with a positive skin test or in vitro reactivity to a perennial aeroallergen (airborne allergen) and symptoms that are inadequately controlled with inhaled corticosteroids. Genentech anticipates hearing from the FDA later this year.

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FDA grants Priority Review for Genentech’s Venetoclax NDA

Wednesday, January 13, 2016

The FDA has accepted the New Drug Application (NDA) and granted Priority Review for Roche Group member Genentech’s venetoclax for the treatment of people with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, including those with 17p deletion. Venetoclax is a small molecule inhibitor of the BCL-2 protein being developed in partnership with AbbVie, and was granted Breakthrough Therapy designation by the FDA in April 2015 for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion.

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C4 Therapeutics collaborates in the new field of TPD therapeutics

Monday, January 11, 2016

C4 Therapeutics will enter into a strategic collaboration with Roche to develop novel treatments in the field of targeted protein degradation (TPD) using C4’s Degronimid technology. C4’s Degronimids represent a new class of small molecules, TPD therapeutics, which target disease-causing proteins and facilitate their rapid destruction and clearance from the cell through the ubiquitin/proteasome system (UPS).

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Oncology Alliance, GNS launch initiative for colorectal cancer

Wednesday, December 16, 2015

The Alliance for Clinical Trials in Oncology, one of the five cooperative research groups in the U.S. sponsored by the National Cancer Institute conducting large multicenter trials in oncology, and GNS Healthcare (GNS), a precision medicine company that applies causal machine learning technology to match health interventions to individual patients and discover new target intervention pathways, have announced a big data initiative.

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