Japan approves Roche's tumour agnostic cancer drug Rozlytrek

Japan has become the first country to approve Roche’s personalised cancer drug Rozlytrek (entrectinib).

Roche added entrectinib to its pipeline through its $1.7 billion buyout of Ignyta at the end of 2017 in a move that brought it into competition with Bayer.

Bayer acquired rights to a rival cancer drug from the same class called Vitrakvi from Loxo, which has been acquired by Eli Lilly.

Rozlytrek is a “tumour agnostic” oral medicine that targets any advanced recurrent solid tumour with neurotrophic tyrosine receptor kinase (NTRK) fusion mutations.

It is the first such medicine approved in Japan that targets NTRK gene fusions, which have been identified in a range of hard-to-treat solid tumour types, including pancreatic, thyroid, salivary gland, breast, colorectal and lung.

Japan’s Ministry of Health Labour and Welfare approved the drug quickly after it was granted “Sakigake” designation.

The data package for this approval includes the pivotal phase 2 STARTRK-2, phase 1 STARTRK-1 and phase I ALKA-372-001 trials.

Data from the phase I/II STARTRK-NG study in paediatric patients were also included in the submission.

The studies enrolled people across 15 countries and more than 150 clinical trial sites. Tumour types evaluated in the studies included breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.

Regulators in Japan are also reviewing Rozlytrek for ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer.

Rozlytrek is under review by the FDA, which has granted a faster six-month priority review, paving the way for a potential US launch later this year.

The European Medicines Agency (EMA) has granted a Priority Medicine (PRIME) designation, setting the stage for a faster development and review.

Rozlytrek is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer.

It can block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK gene fusions.