MSD receives first FDA approval based on specific genetic feature
pharmafile | May 24, 2017 | News story | Research and Development, Sales and Marketing | MSD, Precision Medicine, biomarker, keytruda
In a historic first, MSD (known as Merck in North America) has received approval for its immunotherapy treatment Keytruda in patients with a specific genetic feature, otherwise known as a biomarker. This means that patients who have a biomarker known as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) will be able to receive the treatment.
The accelerated approval needs further studies to reinforce its use across the indication but the significance of this first case of FDA-approved precision medicine has not been lost on experts and the agency itself.
The FDA titled its approval by signalling the approval as a first while acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, Richard Pazdur, referred to the approval as “an important first for the cancer community”.
He continued further to say: “Until now, the FDA has approved cancer treatments based on where in the body the cancer started—for example, lung or breast cancers. We have now approved a drug based on a tumour’s biomarker without regard to the tumour’s original location.”
The response from MSD was slightly more muted, with around 4% of advanced cancers being likely to be eligible for treatment with the indications representing a welcome, but not large, section of the overall market. It could see around 15,000 to 20,000 new patients become eligible to receive the treatment.
The company released a relatively muted statement from Dr Roger Perlmutter, President, Merck Research Laboratories, reading: “The FDA’s approval of this new indication for Keytruda further supports Merck’s commitment to helping people with difficult-to-treat cancers”.
The treatment will have to post further positive results from trials to see whether it retain its approval from the FDA. The approval was based on data from 149 patients with MSI-H or dMMR cancers across five single-arm clinical trials. The results showed that 40% of patients achieved an objective response rate and, of those who responded treatment, 78% had responses that lasted for at least six months.
The results are positive but will need to be reinforced by more data. However, with a first already managed in a drug that treats cancers based on a biomarker established, it could open up the possibility of further approvals based on biomarkers rather than area.
Ben Hargreaves
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