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European Commission approves Roche’s Gavreto to treat adults with RET fusion-positive advanced non-small cell lung cancer

Gavreto is the first and only precision medicine approved in the EU for the first-line treatment of people with RET fusion-positive advanced NSCLC

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Roche recently announced that the European Commission (EC) has granted conditional marketing authorisation for Gavreto (pralsetinib) as a monotherapy for the treatment of adults with Rearranged During Transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. Gavreto is the first and only precision medicine approved in the European Union (EU) for the first-line treatment of people with RET fusion-positive advanced NSCLC, a statement from the company said.

“The approval represents an important step forward in delivering precision medicine to people with RET fusion-positive advanced non-small cell lung cancer, for whom treatment options have historically been limited,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, Roche.

Garraway added, “By using cancer genomic profiling upfront, healthcare professionals may identify specific genetic alterations that predict clinical benefit of targeted treatment options like Gavreto in the first-line setting.”

According to the statement, the approval is based on results of the ongoing phase-I/II Arrow study, in which Gavreto led to durable responses in people with advanced RET fusion-positive NSCLC. In 75 treatment-naïve patients, Gavreto demonstrated an overall response rate (ORR) of 72 per cent (95% CI: 60.4%, 81.8%), and median duration of response (DOR) was not reached (NR) (95% CI: 9 months, NR). In 136 patients who had previously received platinum-based chemotherapy, Gavreto demonstrated an ORR of 58.8 per cent (95% CI: 50.1%, 67.2%), and median DOR was 22.3 months (95% CI: 15.1 months, NR). Gavreto was also generally well-tolerated, with a low rate of treatment discontinuation; common grade three-four adverse reactions were neutropenia (reported in 20.1 per cent of patients), anaemia (17.6 per cent) and hypertension (16.1 per cent).

Approximately, 37,500 people are diagnosed with RET fusion-positive NSCLC worldwide each year. The disease often affects people with minimal to no history of smoking, and who are typically younger than the average person diagnosed with lung cancer. Roche is committed to providing a tailored treatment option for every person with lung cancer, no matter how rare or difficult to treat their type of disease. Gavreto in RET fusion-positive advanced NSCLC, along with Alecensa (alectinib) in ALK-positive advanced NSCLC and Rozlytrek (entrectinib) in ROS1-positive advanced NSCLC, is part of Roche’s growing portfolio of precision medicines. Together, they offer personalised treatment options for almost one-in-ten people with advanced NSCLC, and biomarker testing is the most effective way to identify those people who may benefit, added the statement.

It also said that beyond NSCLC, RET alterations are also key disease drivers in other cancer types, such as thyroid cancers. Gavreto has shown activity across multiple solid tumour types, reflecting tumour-agnostic potential. It is approved by the US Food and Drug Administration (FDA) for the treatment of adults with metastatic RET fusion-positive NSCLC, and for the treatment of adult and paediatric patients 12 years of age and older with advanced RET-altered thyroid cancers. Gavreto is also approved in Canada, mainland China and Switzerland. In the EU, a submission for RET-altered thyroid cancers is planned. Regulatory submissions for advanced RET fusion-positive NSCLC and RET-altered thyroid cancers are also underway in multiple countries worldwide.

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