Thankfully, in June 2021, we reported good news. “A drug sold by AstraZeneca and Merck reduced the recurrence of breast cancer in women with an early but aggressive form of the disease. According to a long-running international study.”. Unfortunately, today we have bad news as Roche pulls the plug on its breast cancer drug.
After Failed Tests: Roche Pulls the Plug on Breast Cancer Drug
To say this is disappointing would be an understatement. Read below to learn why.
As Noah Higgins-Dunn reports for Fierce Pharma:
Just two years ago, Roche’s Tecentriq was heralded as the first PD-1/L1 treatment to win an approval in triple-negative breast cancer. However, the approval was conditional on a post-marketing study on Tecentriq and Celgene’s Abraxane combo that later failed.
Now, Roche is pulling the plug. The Swiss pharma announced that it voluntarily withdrew its accelerated approval for Tecentriq in combination with Abraxane (nab-paclitaxel) for patients with PD-L1-positive metastatic triple-negative breast cancer (mTNBC).
Tecentriq’s approval for late-stage breast cancer patients depended on the follow-up trial. Known as IMpassion131. In that study, combining Tecentriq and paclitaxel did not stall the tumor progression in newly diagnosed PD-L1-positive patients. Even worse, patients taking paclitaxel alone did better than those taking the combo treatment.
In its statement, Roche said the following. It was “working diligently” with the FDA to find another post-approval pathway for its Tecentriq combo. Ultimately, the FDA felt it wasn’t necessary to maintain the accelerated approval given recent changes to the treatment landscape.
For further information from Fierce Pharma, click the image.
