Home Health Care If FDA says ‘make it so,’ Loxo’s Vitrakvi could see competition from...

If FDA says ‘make it so,’ Loxo’s Vitrakvi could see competition from Roche’s entrectinib

111
0
SHARE

Months after the Food and Drug Administration approved one of the first drugs to win a tissue-agnostic, biomarker-driven label, another company hopes to become the second to receive an approval for a drug that targets the same biomarker.

Genentech, part of Swiss drugmaker Roche, said Monday that the FDA had accepted and granted priority review to its application for entrectinib in NTRK fusion-positive, locally advanced or metastatic solid tumors among patients who have progressed on prior therapies or for whom there are no acceptable standard initial therapies. The agency also accepted the application for the drug in ROS1-positive non-small cell lung cancer. It is expected to reach a decision by Aug. 18.

Entrectinib targets NTRK fusions, similar to Loxo Oncology’s Vitrakvi (larotrectinib), which the FDA granted accelerated approval in November. Eli Lilly & Co. said last month it would acquire Loxo for $8 billion. However, whereas Vitrakvi only targets NTRK fusions, entrectinib also targets ROS1, hence the NSCLC filing.

The filing was based on data from several clinical trials, including the Phase II STARTRK-2 study, the Phase I STARTRK-1 and ALKA-372-001 trials and the Phase I/Ib STARTRK-NG trial.

Data from the three studies showed that entrectinib produced an overall response rate, or ORR, of 57.4 percent across 10 solid tumor types, with a median duration of response of 10.4 months. Patients responded whether or not they had central nervous system metastases, and the drug shrank tumors that had spread to the brain in 54.5 percent of patients, with more than a quarter of them experiencing complete remissions.

Vitrakvi’s accelerated approval was based on data from three clinical trials of 55 pediatric and adult patients across several tumor types who showed about an 80 percent ORR. It was the second drug to win a tissue-agnostic label from the FDA, the first one being Merck & Co.’s Keytruda (pembrolizumab), which was approved in 2017 for patients with microsatellite instability-high and mismatch repair-deficient – or MSI-H and dMMR – cancers.

The Loxo drug’s label is for patients who are metastatic, unsuitable for surgical resection and have no alternative treatment or have progressed following treatment.

However, despite the high response rates produced by Vitrakvi and entrectinib, what remains to be seen is whether they will also yield an improvement in overall survival and extend patients’ lives, considered the gold standard of efficacy in oncology treatment. There is also a likelihood that patients can become resistant to therapy, and for that reason Loxo is developing another NTRK inhibitor, LOXO-195, designed to overcome tumors’ resistance mechanisms.

Drugs like Vitrakvi, entrectinib and Keytruda in the case of MSI-H and dMMR cancers – those attacking mutations and fusions that are rare but highly amenable to targeted therapy – have evolved alongside the rise of genomic sequencing in cancer treatment, considered a key component to value-based healthcare.

In other news, the FDA also accepted and gave priority review to Roche’s application for polatuzumab vedotin. The drug is an antibody-drug conjugate that targets CD79b and is designed to be combined with bendamustine and Roche’s Rituxan (rituximab) in relapsed or refractory diffuse large B-cell lymphoma. The agency is expected to rule on that drug by Aug. 19.

Photo: jxfzsy, Getty Images

Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here

three × two =