Roche has secured priority review from the US Food and Drug Administration (FDA) for two of its investigational cancer drugs, the selective tyrosine kinase inhibitor entrectinib (RXDX-101) and the anti-CD79b antibody drug conjugate (ADC) polatuzumab vedotin.
Entrectinib has been granted priority review for the treatment of neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors in adult and paediatric patients.
The designation is for such patient population whose disease had progressed after undergoing prior therapies or for the drug to be used as an initial therapy when there are no acceptable standard therapies, and for the treatment of people having metastatic, ROS1-positive non-small cell lung cancer (NSCLC).
The new drug applications (NDAs) submitted by Roche for the multiple indications are based on results from the integrated analysis of the phase 2 STARTRK-2, phase 1 STARTRK-1 and phase 1 ALKA-372-001 trials, and also from the findings of the phase 1/1b STARTRK-NG study.
Under the priority review designation, the FDA is likely to take a call on entrectinib’s approval by 18 August 2019.
Roche 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.
“By combining comprehensive genomic profiling with actionable targeted therapies, like entrectinib, we are advancing our personalised healthcare goal to find the right treatment for each patient. We are working closely with the FDA to make this potential new option available as soon as possible.”
The other priority review received by Roche from the FDA is for the use of polatuzumab vedotin in combination with bendamustine plus Rituxan (rituximab) [collectively called BR] for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
The FDA is likely to take a decision on the combination therapy’s approval by 19 August 2019.
The company’s Biologics License Application (BLA) for the polatuzumab vedotin combination therapy is based on the findings of the phase 1b/2 GO29365 trial, which demonstrated that polatuzumab vedotin plus BR improved median overall survival in comparison to BR treatment.