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Roche Gets FDA Nod for Gavreto for RET Fusion-Positive NSCLC

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Roche (RHHBY - Free Report) announced that the FDA has approved its pipeline candidate Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The drug can be administered to patients when an FDA-approved test detects this disease.

The nod came under the FDA’s Accelerated Approval program and was based on data from the phase I/II ARROW study.

The study results showed that Gavreto produced durable clinical responses in people with RET fusion-positive NSCLC with or without prior therapy and regardless of the RET fusion partner or the central nervous system involvement.

Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers.

The approval makes Gavreto the sixth FDA-approved drug in Roche’s portfolio for lung cancer. The company’s immuno-oncology drug Tecentriq is also approved as a first-line treatment for adults with metastatic NSCLC. Other approved drugs for lung cancer include Rozlytrek, Alecensa and Avastin among others.

We remind investors that the FDA granted Gavreto a Breakthrough Therapy Designation for the treatment of RET fusion-positive NSCLC that progressed following the platinum-based chemotherapy and for RET mutation-positive medullary thyroid cancer (MTC) that requires systemic treatment and for which there are no acceptable alternative treatments.

Further, the regulatory agency granted a Priority Review to Gavreto for treating people with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer. A decision on the same is expected by Feb 28 2021.

We note that Roche is co-developing Gavreto with Blueprint Medicines (BPMC - Free Report) for attending patients with various types of RET-altered thyroid cancers and other solid tumors. Both companies will co-commercialize Gavreto in the United States while Roche alone will commercialize the drug outside the United States.

Roche’s stock has gained 7.7% in the year so far against the industry’s decline of 0.5%.

The company is a leader in the oncology space and approval of new drugs will further strengthen its portfolio.  Last month, the FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children aged two months and above. SMA is a severe, progressive neuromuscular disease that can be fatal. The FDA also approved the company’s pipeline drug satralizumab-mwge as the first and the only subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Meanwhile, Roche’s performance in the second quarter of 2020 was negatively impacted by the COVID-19 outbreak as patients deferred their routine visits to respective physicians. While the first-quarter show was reasonably good, weak performance in the sequential quarter affected the company’s first-half results.

Strong growth in Roche’s product portfolio comprising Ocrevus, Perjeta, Tecentriq and Hemlibra countered the biosimilar competition for its Herceptin and MabThera from the likes of Amgen (AMGN - Free Report) .

Roche is conducting several late-stage studies for addressing severe COVID-19 pneumonia. Remdacta, a global phase III study, was initiated to evaluate the safety and efficacy of its Actemra/RoActemra in combination with Gilead Sciences’ (GILD - Free Report) antiviral remdesivir.

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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