Two new cancer Priority Reviews for Roche
Roche has announced that the FDA has granted Priority Review to two of its drugs – personalised lung cancer medicine entrectinib and lymphoma treatment polatuzumab vedotin.
Entrectinib is a selective tyrosine kinase inhibitor being developed for non-small cell lung cancer (NSCLC) patients whose tumours carry NTRK fusions or ROS1 fusions.
Pfizer’s Xalkori is already approved to treat patients with ROS1 mutations (alongside its use in ALK+ patients), but entrectinib looks superior, thanks in part to its ability to pass through the blood brain barrier and possibly prevent brain metastases.
“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,” said Sandra Horning, Roche’s chief medical officer and head of global product development.
The drug has also been granted Breakthrough Therapy Designation by the FDA, priority medicines (PRIME) designation by the European Medicines Agency (EMA); and Sakigake designation by the Japanese health authorities.
Roche added entrectinib to its pipeline with it acquired oncology biotech Ignyta for $1.7 billion in 2017, boosting its position in the extremely competitive lung cancer field.
The company says that it is also developing a companion diagnostic to help identify people with ROS1 and NTRK gene fusions in conjunction with Foundation Medicine.
Meanwhile, the Swiss firm’s polatuzumab vedotin has also been granted priority review, in this case for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine plus Rituxan (rituximab).
The application is based on results of the GO29365 study, which showed that polatuzumab vedotin plus bendamustine and Rituxan improved median overall survival compared to bendamustine and Rituxan alone (12.4 vs. 4.7 months) in people with R/R DLBCL not eligible for a haematopoietic stem cell transplant (HSCT).
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