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February 19, 2019

Genentech gets FDA priority review for two cancer drugs

Genentech, a subsidiary of Roche, has secured priority review status from the US Food and Drug Administration (FDA) for two of its oncology drugs, entrectinib and polatuzumab vedotin.

Genentech, a subsidiary of Roche, has secured priority review status from the US Food and Drug Administration (FDA) for two of its oncology drugs, entrectinib and polatuzumab vedotin.

Entrectinib is an investigational, oral, selective tyrosine kinase (TRK) inhibitor designed to block the kinase activity of the TRK A/B/C and ROS1 proteins associated with certain types of cancer.

The drug is being developed as a personalised medicine for adults and children with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumours.

Genentech is seeking approval for patients whose disease has either progressed after previous therapies or as initial treatment when no acceptable standard therapies are available.

The company also submitted an application for use in metastatic, ROS1-positive non-small cell lung cancer (NSCLC) patients.

Evidence for entrectinib includes data from an integrated analysis of the Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 clinical trials, as well as the Phase I/Ib STARTRK-NG trial.

“Entrectinib represents a unique approach to cancer treatment that can potentially target a range of hard-to-treat and rare NTRK fusion-positive tumours regardless of their site of origin, as well as treat ROS1-positive non-small cell lung cancer.”

Data showed that the drug candidate shrank tumours in nearly 57.4% patients with NTRK fusion-positive solid tumours, as well as in 77.4% of those with locally advanced or metastatic ROS1-positive NSCLC.

Genentech chief medical officer and Global Product Development head Sandra Horning said: “Entrectinib represents a unique approach to cancer treatment that can potentially target a range of hard-to-treat and rare NTRK fusion-positive tumours regardless of their site of origin, as well as treat ROS1-positive non-small cell lung cancer.”

The FDA has also accepted biologics license application (BLA) for polatuzumab vedotin in combination with bendamustine plus Rituxan (rituximab) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Polatuzumab vedotin is an anti-CD79b antibody drug conjugate, which binds to CD79b and destroys B-cells via a targeted approach.

The BLA submitted to the regulatory agency is based on findings obtained from the Phase Ib/II GO29365 trial assessing the safety, tolerability and activity of the polatuzumab vedotin combination.

Results demonstrated improved median overall survival with the combination therapy, compared to bendamustine plus Rituxan alone, in relapsed and refractory DLBCL patients not eligible for a hematopoietic stem cell transplant.

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