Roche Voluntarily Withdraws U.S. Accelerated Approval of Tecentriq Plus Chemotherapy for PD-L1-Positive Metastatic Triple-Negative Breast Cancer

Aug 29, 2021 15:06 CST Updated 15:06

Roche

Oncology Drug Research, Development, and Manufacturing

Roche recently announced that it has decided to voluntarily withdraw a U.S. accelerated approval for the anti-PD-L1 therapy Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel [nab-paclitaxel]), for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1, as confirmed by an FDA-approved test.

Following consultation with the U.S. Food and Drug Administration (FDA), Roche made this decision based on the FDA’s assessment of the current treatment landscape for mTNBC and in accordance with the requirements of the Accelerated Approval program. This decision affects only the mTNBC indication in the United States and does not impact other approved indications for Tecentriq, including mTNBC, both within and outside the U.S. It is not related to any changes in the efficacy or safety profile of Tecentriq.

In March 2019, the U.S. FDA granted accelerated approval to Tecentriq for the mTNBC indication, making it the first immunotherapy approved in this setting. This approval was based on positive progression-free survival (PFS) results from the Phase 3 IMpassion130 study in patients with mTNBC whose tumors expressed PD-L1 (≥1%). Continued approval for this indication was contingent upon the results of the IMpassion131 study, which was a post-marketing requirement (PMR) for this mTNBC indication. However, the results showed that the IMpassion131 study failed to meet its primary endpoint of improving PFS in patients with PD-L1-positive mTNBC receiving initial (first-line) treatment.

The FDA Oncologic Drugs Advisory Committee (ODAC) discussed the results of these two studies, voting 7 to 2 on April 27, 2021, in favor of maintaining the accelerated approval of Tecentriq in combination with chemotherapy (Abraxane) for the treatment of PD-L1-positive mTNBC. Since then, Roche has been working with the U.S. FDA on a potential alternative PMR. However, due to recent changes in the treatment landscape, the FDA no longer considers maintaining the accelerated approval appropriate. This has led to the difficult decision to voluntarily withdraw the U.S. mTNBC indication.

Roche will work with the FDA over the coming weeks to complete the withdrawal process. Roche is notifying healthcare professionals in the United States regarding this withdrawal. In the United States, patients with PD-L1-positive mTNBC receiving treatment with Tecentriq should discuss their care with their healthcare provider.

The extensive development program for Tecentriq encompasses multiple ongoing and planned Phase 3 studies covering a range of cancer types, including lung cancer, genitourinary cancer, skin cancer, breast cancer, gastrointestinal cancer, gynecologic cancer, and head and neck cancer. This includes studies evaluating Tecentriq as monotherapy or in combination with other therapeutic agents, as well as studies conducted in the metastatic, adjuvant, and neoadjuvant settings.

Tecentriq is a PD-(L)1 cancer immunotherapy that targets and binds to the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq can activate T cells.

To date, Tecentriq has been approved in multiple countries as monotherapy and in combination with targeted therapy and/or chemotherapy for the treatment of various types of cancer, including: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), certain types of metastatic urothelial carcinoma (mUC), PD-L1-positive triple-negative breast cancer (TNBC), hepatocellular carcinoma (HCC), and melanoma, among others. (Bioon.com)

Source: Roche provides update on Tecentriq US indication for PD-L1-positive, metastatic triple-negative breast cancer

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