Top 3 drug approvals March 2023: Zynyz®, Calquence®, Keytruda®
The US FDA is reigning in their accelerated approval program, as it received criticism over approvals based on single-arm clinical trials, meaning a drop in drug recommendations. Despite that, this month has seen new treatment modalities being given the green light for Merkel cell carcinoma, cervical cancer and mantle cell lymphoma.
Zynyz® (retifanlimab-Dlwr)
Approved: 22 March 2023
Approving body: US FDA
Indication: Merkel cell carcinoma
March saw Incyte (DE, USA) gain its first approval for a PD-1 inhbitor, the drug termed Zynyz™ was given the green light by the FDA for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.
“More than a third of patients with Merkle cell carcinoma present with regional or distant metastases, which are associated with high rates of mortality. The approval of Zynyz offers healthcare providers another first-line treatment option against MCC that can result in durable responses in patients with metastatic disease,” commented Shailender Bhatia (University of Washington and Fred Hutchinson Cancer Center, both WA, USA).
The approval is based on data from the POD1UM-201 trial, which analyzed the effects of the drug on 107 patients. Among 65 chemotherapy-naïve patients, Zynyz monotherapy resulted in a 52% overall response rate, with a complete response rate of 18%. Among the responders, 76% had a duration of response of at least 6 months, while 62% achieved a DOR lasting 1 year or more.
Calquence® (acalabrutinib)
Approved: 23 March 2023
Approving body: National Medical Products Administration
Indication: Mantle cell lymphoma
China’s National Medical Products Administration has given its conditional approval for Calquence® for adult patients with mantle cell lymphoma, based on data from two clinical trials. The drug is already approved in the USA for the same condition, however, has yet to gain approval for mantle cell lymphoma in Europe or Japan.
Jun Zhu (Peking University Cancer Hospital, Beijing, China) commented: “Mantle cell lymphoma progresses rapidly and responds poorly to conventional treatment such as immunochemotherapy. Before the emergence of BTK inhibitors, there were few satisfactory treatment options for patients. The next-generation BTK inhibitor Calquence has higher target selectivity, fewer side effects, and a higher response rate compared to currently available treatments.
Keytruda ® (pembrolizumab)
Approved: 29 March 2023
Approving body: NICE
Indication: Cervical cancer
NICE recently published draft guidance recommending the ever-popular immunotherapy Keytruda® with chemotherapy (with or without bevacizumab) as an option for treating persistent, recurrent or metastatic cervical cancer. The therapy is specifically approved for adults whose tumours express PDL1 with a combined positive score of at least 1, if the pembrolizumab is stopped at 2 years of uninterrupted treatment.
“This has been made possible by the government’s £340 million Cancer Drugs Fund, which has helped thousands of patients to benefit from rapid access to promising new cancer treatments,” Health Minister Helen Whately commented.
