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Roche’s Tecentriq combo scores FDA approval for melanoma

Drug approved for patients with BRAF protein mutations


Roche has announced that the US Food and Drug Administration (FDA) has approved its PD-L1 inhibitor as a treatment for certain advanced melanoma patients.

Tecentriq, plus MEK inhibitor Cotellic (cobimetinib) and BRAF inhibitor Zelboraf (vemurafenib), has been backed for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The BRAF protein is mutated in approximately half of all melanoma patients.

The approval is based on the results from Roche’s phase 3 Imspire150 study of the Tecentriq combination, in which the treatment improved median progression-free survival – demonstrating a PFS of 15.1 months compared to 10.6 months in the placebo arm.

"When receiving a cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening," said Levi Garraway, Roche’s Genentech division’s chief medical officer and head of global product development.

"The FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma," he added.

For Roche, the approval in melanoma is a win given that its plans to build a market for the Tecentriq/Cotellic combo took an early hit when the duo missed the mark in advanced colorectal cancer.

However, Roche is likely to face fierce competition from rival checkpoint inhibitors, namely Merck & Co’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo which have already been on the market for a number of years as melanoma treatments.

In fact, Keytruda was first approved for advanced melanoma back in September 2014, when it became the first drug in the PD-1/L1 class to gain approval in the US.

Opdivo, on the other hand, was first approved as a treatment for both first-line and previously-treated patients with advanced melanoma, regardless of whether they carry the BRAF mutation, in 2015.

Aside from melanoma, Roche has multiple ongoing and planned phase 3 studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies that are evaluating Tecentriq as a monotherapy and in combination with other targeted medicines.

Article by
Lucy Parsons

31st July 2020

From: Regulatory



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