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FDA panel votes to keep accelerated approval for Roche’s Tecentriq in breast cancer

Oncologic Drugs Advisory Committee voted seven to two in favour of drug

A US Food and Drug Administration (FDA) panel has voted in favour of maintaining the accelerated approval for Roche’s Tecentriq in breast cancer, amid a major review of cancer drugs that have failed to meet post-marketing requirements. 

Earlier this year, the FDA announced that it would convene its Oncologic Drugs Advisory Committee (ODAC) to discuss six oncology indications with accelerated approvals, including Tecentriq (atezolizumab), Merck and Co’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) in breast, urothelial, gastric and hepatocellular cancers.

The review comes after a number of drugmakers decided to voluntarily withdraw indications for their respective therapies after post-marketing studies failed to demonstrate continued clinical benefit following initial accelerated approvals.

In its first meeting, the ODAC voted seven to two in favour of keeping the accelerated approval for Tecentriq  in combination with chemotherapy for the treatment of adults with locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1.

Initially, the FDA granted the Tecentriq/chemotherapy accelerated approval in this indication in March 2019 based on positive progression-free survival (PFS) results from the IMpassion130 study.

The continued approval of Tecentriq was contingent on results from the IMpassion131 study, although this study did not meet its primary endpoint of PFS for the first-line treatment of people with metastatic TNBC with PD-L1 tumour expression.

Despite this failure, the ODAC ultimately maintained the accelerated approval due the initial clinically meaningful benefit demonstrated in the IMpassion130 study.

However, it’s unclear what specific steps Roche will take to continue to demonstrate the benefit of Tecentriq in this indication.

Cryptically, Roche’s Genentech division simply said in a statement that it “looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication”.

“People with triple-negative breast cancer have few treatment options, which is why today's committee decision to recognise the importance of this Tecentriq combination is significant,” said Levi Garraway, chief medical officer and head of global product development, Roche.

“We are grateful to the FDA and ODAC for the open dialogue and look forward to continued collaboration to improve the lives of people with breast cancer,” he added.

The ODAC is set to reconvene today to discuss the accelerated approval for Tecentriq as a treatment for people with locally advanced or metastatic urothelial carcinoma (bladder cancer).

Article by
Lucy Parsons

28th April 2021

From: Regulatory



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