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Genentech’s Hopes For Keeping Tecentriq Breast Cancer Claim May Rest With Trial In Early Disease Recurrence

Executive Summary

Even though IMpassion132 is enrolling a different population and has a different chemotherapy backbone, it could confirm atezolizumab’s benefit for patients with advanced triple-negative breast cancer whose tumors express PD-L1, agency says ahead of advisory committee meeting on accelerated approval indications with failed confirmatory trials.

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Genentech’s Tecentriq Should Keep Its Accelerated Approval In Breast Cancer For Now, ODAC Says

Although US FDA panelists said that ideally a new confirmatory trial would be conducted in the same triple-negative breast cancer population, they acknowledged the sponsor’s feasibility concerns and suggested instead that the IMpassion132 trial, expected to report in 2023, might suffice.

PD-1 Inhibitor Market Poised For A New Round Of Expansion: After GSK’s Jemperli Approval, US FDA Still Has Three Novel Candidates Under Review

Agenus’ recent submission of balstilimab joins novel checkpoint inhibitors from Incyte expecting FDA action this year; Junshi and Coherus’ ongoing rolling BLA for toripalimab is the first from the multiple PD-1/L1 inhibitor candidates developed in China that are vying to enter the US market.

‘Dangling’ Accelerated Approvals: US FDA Flags Concerns About ‘Marginal’ Response Rates

Failed confirmatory trials for PD-1/L-1 inhibitor indications raise questions about marginal response rates in single-arm trials used to support accelerated approval, Oncology Center of Excellence leaders say in NEJM article that explains why the agency is taking six of these indications to its Oncologic Drugs Advisory Committee.

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