Basel, 27 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the company has made the decision to voluntarily withdraw the US accelerated approval for Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1, as determined by a US Food and Drug Administration (FDA)-approved test. Roche made this decision following consultation with the US FDA, based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval programme. This decision only impacts the mTNBC indication in the US. It does not affect other approved indications for Tecentriq in the US and outside the US, including mTNBC. This is not related to any changes in either the efficacy or safety associated with Tecentriq.
“TNBC remains the most challenging type of breast cancer to treat, which makes the decision to withdraw so difficult for us, as patients have had this medicine as an important option for more than two years,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We appreciate the opportunity to have been able to help people with mTNBC in the US with Tecentriq through the accelerated approval process, which has brought many significant and novel therapies to patients. We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”
Tecentriq was granted accelerated approval by the FDA for the mTNBC indication in March 2019, making it the first immunotherapy agent to be approved in this setting. Approval was based on the progression-free survival (PFS) results of the Phase III IMpassion130 study for people with mTNBC whose tumours express PD-L1 (≥1%). Continued approval for this indication was contingent upon the results of IMpassion131, the postmarketing requirement (PMR). This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. The results of both studies were discussed at the FDA Oncology Drugs Advisory Committee (ODAC), which voted 7 to 2 on 27 April 2021 in favour of maintaining the accelerated approval of Tecentriq in combination with nab-paclitaxel for the treatment of people with PD-L1-positive mTNBC. Since then, Roche has been working diligently with the FDA on a possible alternative PMR. However, due to the recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval. This led to the difficult decision to voluntarily withdraw the US mTNBC indication.
Roche will work with the FDA over the coming weeks to complete the withdrawal process. Roche is notifying healthcare professionals in the US about this withdrawal. Patients in the US being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider.
Roche is committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first-in-class medicine approved for particularly difficult-to-treat cancers. Tecentriq’s extensive development programme includes multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings.
