Roche pulls dangling accelerated approval for Tecentriq in triple-negative breast cancer – Endpoints News

Roche decided Friday to voluntarily pull an indication won through the FDA’s accelerated approval process for its blockbuster PD-L1 drug Tecentriq.

This is the third accelerated approval to be withdrawn after an ODAC meeting last April to review six indications of Roche, Merck and Bristol Myers Squibb blockbuster cancer drugs, where confirmatory studies failed. This is also the fourth accelerated approval to be withdrawn in the past month.

The move to pull Tecentriq in combination with chemo for the treatment of adults with inoperable locally advanced or metastatic triple-negative breast cancer comes after the FDA’s oncology drugs voted 7-2 to let it dangle, while other, additional confirmatory investigations were underway.

But Roche said it came to its decision following recent discussions with the FDA about another post-marketing study, and “because of recent changes in the treatment landscape,” which the company says means the FDA “no longer deems it appropriate to extend the accelerated approval.” to enforce .”

With limited other treatment options at the time, Tecentriq initially won its accelerated OR in combination with nab-paclitaxel for adult patients with mTNBC whose tumors expressed PD-L1 in March 2019, based on a median progression-free survival of 7.4 months , compared to 4.8 months for those who received placebo in combination with nab-paclitaxel.

But the confirmatory trial did not pan out and even showed a worrying sign, as the placebo outperformed the treatment combination in terms of overall survival.

Presenting before the FDA at the ODAC meeting, Laleh Amiri-Kordestani, division director at the Office of Oncologic Diseases, noted that the overall survival results in the first trial (on which the accelerated approval was based) were due only to chance, and that the benefit seen in the first trial was not confirmed in a comparable population in the confirmatory trial.

Roche emphasized that Friday’s decision only affects the mTNBC indication in the US and does not affect other approved indications for Tecentriq in the US and outside the US. In 2020, Tecentriq brought in nearly $3 billion in worldwide sales.

Also after that high-stakes ODAC meeting in April, Merck agreed last month to pull a third-line indication for stomach cancer for its blockbuster Keytruda, which received a thumbs down from ODAC after the late-stage confirmatory studies produced no clinical benefit. And Bristol Myers also withdrew an ODAC-assessed indication late last month for Opdivo as monotherapy for hepatocellular carcinoma patients previously treated with sorafenib.

Overall, the outside experts voted to recommend withdrawing two of the six reviewed indications, both of which have now been withdrawn, in addition to Roche’s decision. It remains unknown what may happen for the other two indications reviewed at the meeting.

Separately, Bristol Myers also withdrew an Istodax indication for peripheral T-cell lymphoma in early August after a Phase III confirmation trial for the drug failed on its progression-free survival endpoint.

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