FDA approves additional recommended dosage for anti-PD-1 therapy

May 13, 2020

The FDA approved an additional recommended dosage of 400 mg every 6 weeks for the anti-PD-1 therapy pembrolizumab (Keytruda), across all adult indications, including monotherapy and combination therapy, Merck reported.

The FDA approved an additional recommended dosage of 400 mg every 6 weeks for the anti-PD-1 therapy pembrolizumab (Keytruda), across all adult indications, including monotherapy and combination therapy, Merck reported.

This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials. This new dosage option will be available in addition to the current dose of 200 mg every 3 weeks, according to Merck.

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Pembrolizumab has a number of genitourinary cancer indications. It is indicated for:

• the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status

• the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

• the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Pembrolizumab, in combination with axitinib, is also indicated for the first-line treatment of patients with advanced renal cell carcinoma.

“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” said Roy Baynes, MD, PhD, of Merck Research Laboratories. “[The] approval of an every 6-week dosing schedule for KEYTRUDA gives doctors an option to reduce how often patients are at the clinic for their treatment.”

Commenting on the announcement, Arjun Balar, MD, told Urology Times©: The newly approved dosing provided additional flexibility and convenience for patients, especially for those who have already achieved disease control with treatment and can now enjoy extended times between treatment visits.

“The safety and efficacy profile of every 6 weeks and every 3 weeks dosing should be identical. Therefore, whether you’re choosing every 6 weeks or 3 weeks dosing, it’s important to recognize that vigilance and monitoring for immune-related toxicities should be no different. Keeping in close contact with patients and early intervention for immune-related toxicities is particularly critical,” advised Balar, of NYU Langone Health.

Disclosures: Balar is a consultant/adviser for Genentech, Incyte, Janssen, Merck, Pfizer, AstraZeneca/Medimmune, Nektar, and Seattle Genetics. He has received institutional funding from Genentech, Merck, AstraZeneca/Medimmune, Seattle Genetics, and Immunomedics.