A partnership between Bristol Myers Squibb and BeiGene on the chemotherapy Abraxane in China has quickly deteriorated since a manufacturing-related marketing hold last March. Now, the U.S. pharma is scrapping the deal—much to the Chinese partner’s disagreement.
Roche has decided to voluntarily withdraw the US accelerated approval for Tecentriq (atezolizumab) in combination with Abraxane (nab-paclitaxel) to treat patients with PD-L1-positive metastatic triple-negative breast cancer (mTNBC).
The FDA kicked off its three-day meeting on accelerated approvals of immuno-oncology drugs by picking apart one of the biggest players in the field, Roche’s Tecentriq, a PD-L1 inhibitor that the pharma giant has been counting on to replace sales lost to biosimilar competition on other blockbusters. In the end, advisers voted to keep the med's approval in place while further studies play out.
In a Phase III study, Genentech’s Tecentriq (atezolizumab) in combination with Celgene’s Abraxane followed by chemotherapy demonstrated a statistically significant and clinically meaningful improvement in treating patients with early triple-negative breast cancer.
Months after Roche secured US approval for its checkpoint inhibitor Tecentriq, in combination with Celgene’s Abraxane, for frontline use in an aggressive, tough-to-treat subgroup of breast cancer patients — the EU has followed suit.
Hard on the heels of an FDA approval for Roche’s Tecentriq and Celgene’s Abraxane for triple-negative breast cancer (TNBC), the regimen has been cleared for early access in the UK.
Although Abraxane failed to hit the mark in the pancreatic cancer study, it recently won approval in combination with Genentech's Tecentriq for breast cancer.
The FDA has granted a fast review for Roche/Genentech’s Tecentriq in combination with Celgene’s Abraxane for certain patients with tough-to-treat ‘triple negative’ breast cancer.
Fast on the heels of a key success for small cell lung cancer, Roche’s Tecentriq team at Genentech has scored another frontline win for the pharma giant.