Please login to the form below

Not currently logged in

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



COVID-19 Updates and Daily News

Featured jobs


Add my company

90TEN is a global healthcare communications consultancy with a mission to make people healthier and happier through life-changing education and...

Latest intelligence

Patient-centricity in improving patient recruitment advertising
This blog looks into the importance of concepts and patient centricity in patient recruitment....
AI and life sciences
AI: the smart money is on the smart thinking
Looking at the three key areas where AI is being applied: drug discovery, clinical decision-making and clinical trials...
Virtual Engagement At Porterhouse: Reflections on the past few months
A look at how the pitfalls of virtual engagement can be avoided and the key advantages of virtual client and KOL engagement strategies in a now predominantly digital world....