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AbbVie and Roche Receive Successful Phase 2 Data for Blood Cancer Drug
An oncology compound from AbbVie (NYSE:ABBV) and Roche’s (OTCMKTS:RHHVF) Genetech division received promising results from a Phase 2 trial. This data suggests that there may be an FDA filing by the end of the year.
An oncology compound from AbbVie (NYSE:ABBV) and Roche’s (OTCMKTS:RHHVF) Genetech division received promising results from a Phase 2 trial. This data suggests that there may be an FDA filing by the end of the year.
According to Fierce Biotech:
The drug, venetoclax, met its main goal of beating back cancer cells in patients with a form of chronic lymphocytic leukemia (CLL), the companies said. AbbVie and Genentech aren’t yet disclosing detailed data from the 157-patient trial, adding only that its safety profile was in line with previous studies. The companies plan to present full results at a later medical meeting.
Venetoclax, formerly ABT-199, is designed to block the protein B-cell lymphoma-2, which can help cancer cells survive in the blood. The drug’s first target is patients who have CLL with a 17p deletion, a tough-to-treat variant that accounts for up to 10% of all CLL cases and as many as half of all relapsed or refractory instances of the cancer, according to AbbVie.
With positive Phase II data in hand, AbbVie and Genentech plan to submit venetoclax for U.S. approval by the end of 2015. The drug’s promise in CLL convinced the FDA to confer its coveted breakthrough-therapy designation in May, granting the companies access to top agency officials and a shot at an accelerated approval.
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