FDA approves Roche's "tumour agnostic" drug Rozlytrek

The FDA has approved Roche’s Rozlytrek (entrectinib), a so-called “tumour agnostic” drug that is approved to key into certain mutations in cancer, instead of where the disease originates. 

Along with patients aged over 12 with neurotrophic tyrosine receptor kinase (NTRK) solid tumours without a resistance mutation who have no other alternatives available, Rozlytrek is also approved in adults with ROS1-positive metastatic non-small cell lung cancer (NSCLC). 

The Swiss pharma's drug competes directly with Bayer’s Vitrakvi (larotrectinib), which also targets solid tumours with an NTRK gene fusion mutation. 

The FDA has granted an early accelerated approval, reserved for badly needed new medicines for serious or life-threatening diseases. 

Trials so far have provided supportive data about tumour response rate and durability of response, but further studies providing survival data will be needed to maintain Rozlytrek’s licence in the long term. 

Approvals are based on results from the integrated analysis of the pivotal phase 2 STARTRK-2, phase 1 STARTRK-1 and phase 1 ALKA-372-001 trials, and data from the phase 1/2 STARTRK-NG study. 

These trials studied Rozlytrek in several tumour types including breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers. 

In ROS1-positive, metastatic NSCLC, Rozlytrek shrank tumours in 78% of a group of 51 people with the disease and the duration of response (DoR) ranged from 1.8 to 36.8+ months. 

Rozlytrek also shrank tumours in 57% of a group of people with NTRK gene fusion-positive, locally advanced or metastatic solid tumours, and objective responses were observed across 10 tumour types. 

Duration of response ranged from 2.8 months to 26 months and objective responses to Rozlytrek were seen in people with central nervous system metastases at baseline. 

Japanese regulators approved Rozlytrek last month, and the European Medicines Agency has also granted a fast review of the drug, which analysts forecast could produce peak sales in the region of $700-$900 million per year.