Merck’s vaunted checkpoint inhibitor Keytruda has picked up another regulatory approval. The U.S. Food and Drug Administration (FDA) approved
an additional recommended dosage of 400 mg every six weeks for the
anti-PD-1 therapy across all adult indications, including as a
monotherapy and in combination treatments.
Roy Baynes, head of global clinical development and chief medical
officer at Merck Research Laboratories, said the latest dosing approval
is beneficial to cancer patients especially during the COVID-19 pandemic
when social distancing has become an essential tool in limiting the
spread of the disease. But, that social distancing has become a
challenge, particularly for oncology patients who are dependent upon
visiting their doctors for treatment.
Today’s approval of an every six-week dosing schedule for Keytruda
gives doctors an option to reduce how often patients are at the clinic
for their treatment,” Baynes said in a statement.
Merck noted that during the pandemic, the company is committed to ensuring its medications reach its patients.
On Tuesday, Merck said the latest regulatory win was made under
accelerated approval based on pharmacokinetic data revealed in some
ongoing trials. In fact, this week at the virtual American Association for Cancer Research (AACR)
Annual Meeting, Merck revealed interim data from Cohort B of
KEYNOTE-555, a Phase I trial evaluating a 400 mg every six-week dosing
regimen of Keytruda that demonstrated efficacy and safety comparable to
findings from previous melanoma trials evaluating the anti-PD-1 drug as a
monotherapy. In its announcement, Merck said continued approval for the
400 mg dosing every six weeks could 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 three weeks.
Keytruda is expected to become the world’s top-selling drug
over the next few years. The checkpoint inhibitor has been approved for
use in various indications more than 20 times by the FDA and is on
track for additional approvals, such as in breast cancer. In January,
Keytruda posted positive results in the pivotal Phase III KEYNOTE-355 trial
in combinations with chemotherapy in patients with metastatic
triple-negative breast cancer whose tumors expressed PD-L1. The trial
met one of its dual primary endpoints, progression-free survival.
In August, BioSpace took a deep dive into Keytruda and
the impact it has had on treating multiple types of cancer, including
melanoma, non-small cell lung cancer, small cell lung cancer, head and
neck cancer, classical Hodgkin Lymphoma, primary mediastinal large
B-cell lymphoma, urothelial carcinoma, microsatellite instability-high
(MSI-H) cancer, gastric cancer, esophageal cancer, cervical cancer,
hepatocellular carcinoma, Merkel Cell Carcinoma and renal cell
carcinoma.
https://www.biospace.com/article/fda-approves-new-6-week-dosing-for-keytruda-which-benefits-patients-during-pandemic/
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