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25-05-2017 | FDA | Drug approval | News


Pembrolizumab receives agnostic approval for MSI-H/dMMR tumors


medwireNews: The FDA has granted pembrolizumab the first ever tissue- or site-agnostic approval, for the treatment of unresectable or metastatic solid tumors that show high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).

The accelerated approval and priority review status for the programmed cell death 1 receptor inhibitor was given for adult and pediatric patients who have progressed on prior therapy, including fluoropyrimidine, oxaliplatin and irinotecan for those with colorectal cancer, and have no satisfactory alternative options.

The recommendations follow data from five clinical trials in 90 patients with colorectal cancer and 59 patients with one of 14 other tumor types. The objective response rate (ORRs) reported for these two groups were 36% and 46%, respectively.

Pembrolizumab 200 mg may be given to adults as a 30-minute infusion every 3 weeks for up to 2 years. The recommended pediatric dose is 2 mg/kg up to a maximum of 200 mg, although the FDA has included a “Limitation of Use” on this indication as the safety and efficacy of pembrolizumab in children with MSI-H tumors of the central nervous system has not yet been demonstrated.

Pembrolizumab has also been granted accelerated approval by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma in patients who are ineligible for cisplatin-based chemotherapy, based on the ORR achieved during the KEYNOTE-052 trial.

In addition, pembrolizumab was given regular approval for a second group of locally advanced or metastatic urothelial carcinoma patients following overall survival and ORR results from the KEYNOTE-045 trial.

Specifically, the drug may be prescribed to patients who have experienced disease progression during or within 12 months of receiving platinum-containing chemotherapy or within a year of receiving a neoadjuvant or adjuvant platinum-based regimen.

By Lynda Williams

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