Genentech bags Rozlytrek FDA approval for two rare types of cancer

Rozlytrek FDA approval : Roche’s subsidiary Genentech has bagged approvals for Rozlytrek (entrectinib) from the US Food and Drug Administration (FDA) for a type of non-small cell lung cancer (NSCLC) and for certain forms of solid tumors.

The first Rozlytrek FDA approval is for the treatment of ROS1-positive, metastatic NSCLC in adult patients.

Additionally, Rozlytrek has bagged an accelerated approval from the FDA for the treatment of adults and children older than 12 years suffering from solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation. The accelerated approval is for such patients whose condition is metastatic or where surgical removal is expected to lead to severe morbidity, and those whose condition had progressed after treatment or do not have any satisfactory alternative therapy.

Rozlytrek, which is intended to be taken orally, is a selective tyrosine kinase inhibitor. The Roche cancer drug has been designed to prevent the kinase activity of the TRK A/B/C and ROS1 proteins, and could lead to the death of cancer cells through ROS1 or NTRK gene fusions.

Roche’s Genentech secures Rozlytrek FDA approval for two rare types of cancer. Photo courtesy of F. Hoffmann-La Roche Ltd.

Basis of the Rozlytrek FDA approval for the two indications

The two Rozlytrek FDA approvals have been driven on the basis of data acquired from the integrated analysis of the phase 2 STARTRK-2, phase 1 STARTRK-1 and phase 1 ALKA-372-001 trials, and also data from the phase 1/2 STARTRK-NG clinical trial.

The clinical trials were conducted on about 355 people across 15 countries in 150 plus clinical trial sites.

In the clinical analysis, Rozlytrek was tested in multiple solid tumour types like breast, neuroendocrine, non-small cell lung, sarcoma, salivary gland, pancreatic, and thyroid cancers.

The clinical trials showed that treatment with Rozlytrek reduced the size of tumors in 78% of patients with ROS1 -positive, metastatic NSCLC and the duration of response (DoR) was in the range of 1.8 to 36.8 plus months.

The tyrosine kinase inhibitor was also demonstrated to have shrank tumors in more than 50% of the patients with NTRK gene fusion-positive, locally advanced or metastatic solid tumors. The objective responses noted down across 10 tumor types had a DoR ranging from 2.8 to 26.0 plus months.

According to Genetech, the only way to identify patients’ eligibility for treatment with Rozlytrek is through bio-marker testing for ROS1 in NSCLC and NTRK gene fusions in all solid tumors.

Sandra Horning – Roche chief medical officer and head of Global Product Development, commenting on Rozlytrek FDA approval, said: “Rozlytrek’s FDA approval for two rare types of cancer is an important advance for patients, combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting.

“Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain.”

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