Drug maker wins priority review for its new ADCs polatuzumab vedotin and entrectinib.
Roche is facing stiff competition from generics for its top three cancer drugs. The company is fighting back, though. It recently won priority review for two of its investigational cancer therapies –– the antibody-drug conjugate (ADC) polatuzumab vedotin for relapsed or refractory diffuse large B cell lymphoma (DLBCL) and entrectinib for neurotrophic tropomyosin receptor kinase (NTRK) fusion–positive, locally advanced or metastatic solid tumors in patients whose cancer has progressed despite therapy and for metastatic ROS-1 positive non-small cell lung cancer (NSCLC).
Polatuzumab vedotin is an anti-CD79b ADC for treatment of B cell non-Hodgkin lymphoma patients that relapse after receiving first-line treatment (~40%). It binds to CD79b and delivers a cytotoxic drug to the tumor while minimizing damage to healthy cells. The ADC is being reviewed by the FDA in combination with bendamustine and Rituxan (BR). The triple therapy has been designated a breakthrough therapy. Priority review, which should be completed by no later than August 19, 2019, was granted based on the result of an 80-patient study in heavily pre-treated subjects that showed that the triple combination provided better results with respect to median overall survival than treatment with BR alone. Patient receiving the triple therapy lived 12.4 months longer compared wtih placebo vs. 4.7 months longer for patients receiving the BR combination. In addition, 40% of patients receiving the triple therapy achieved complete response compared with just 18% for those receiving only BR.
Roche acquired entrectinib in 2017 when it bought out Ignyta for $1.7 billion. Also designated a breakthrough therapy, it will face competition from Bayer’s Vitrakvi. The first drug approved by the FDA for NTRK fusion cancers was Pfizer’s Xalkori for NSCLC. FDA’s decision on entrectinib is expected by August 18, 2019.