Roche submitted an application to the European Union for the kidney cancer drug Tecentriq/Avastin

Roche chose to withdraw its application in Europe for a dual treatment for renal cell carcinoma based on checkpoint inhibitors Tecentriq and Avastin, citing insufficient support data.
combination of the PD-L1 inhibitor Tecentriq (atezolizumab) and the anti-VEGF drug avastin (bevacizumab) is at the heart of Roche's immune oncology strategy, but it will have to wait a while before it can be pushed to the most common form of kidney cancer, renal cell carcinoma.
Based on phase 2 IMmotion151 research, Roche is seeking approval for Tecentriq and Avastin as first-line treatments for advanced or metastatic renal cell carcinoma, a study that shows that the combination reduces progression-free survival (PFS) by 26 percent compared to Pfizer's Sutent, the standard first-line therapy.
results, which were announced months ago, have been submitted to other regulators, including the FDA, but a Roche spokesman said all applications had been withdrawn.
ema's Human Medicines Commission (CHMP) said Roche chose to withdraw the application through a letter saying the results were "not sufficient to support prolonged adaptation at this time" and that the trial would continue the next analysis of overall survival.
't know when. "Since IMmotion151 is a study of driver events, we are waiting for the data to mature." The spokesman added: "We believe that the combination of Tecentriq and Avastin may play a role in the treatment of metastatic renal cell carcinoma, which remains an area that does not meet high medical needs." "
this is not the first time the Roche Tecentriq/Avastin portfolio has overseen the chain. A few weeks ago, the U.S. Food and Drug Administration said that based on the IMpower150 study, more time was needed to review applications for first-line applications in non-small cell lung cancer (NSCLC) and delay its conclusion by three months. In this trial, Tecentriq and Avastin were compared with chemotherapy in non-scaly NSCLC.CHMP changed its view of Opdivo / Yervoyat the CHMP meeting last week had better news for patients with another combination of renal cell carcinoma, and has now recommended that the panel approve it.
combination of Bristol-Myers Squibb's PD-1 inhibitor Opdivo and CTLA4 inhibitor Yervoy (ipilimumab) was rejected by CHMP earlier this year on the grounds that adding low-dose Yervoy seemed to offer a little extra benefit than Opdivo alone, but added a burden of side effects. The U.S. Food and Drug Administration approved the drug's new use in April.
after re-examining the CheckMate-214 trial and comparing the combination to Sutt, which is the basis for the application, CHMP now increases the clinical importance of patient survival and acceptable side effects, opening the door to EMA approval in the coming weeks.
's good news for BMS, which has been trying to defend its sales forecast for Opdivo, because of a series of positive test readings from PD-1 inhibitor Keytruda, a rival to Merck and Co/MSD, including impressive survival data. In the Phase 3 KEYNOTE-426 trial, reported at this year's ESMO conference, it was used with Pfizer's Inlyta. (This net special draft)