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FDA Approvals Roundup: Jemperli and Zynlonta

Posted 28 April 2021 | By Renee Matthews 

FDA Approvals Roundup: Jemperli and Zynlonta

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New approvals
Jemperli nabs approval for advanced endometrial cancer with specific biomarker
GlaxoSmithKline’s Jemperli (dostarlimab-gxly) has been granted accelerated approval for treating adults with recurrent or advanced endometrial cancer whose tumors are mismatch repair deficient (dMMR) and in whom disease has progressed despite previous treatment.
 
FDA concurrently approved Roche’s Ventana MMR RxDx panel,  a companion diagnostic assay  for determining patient eligibility for Jemperli. This latest approval is a label expansion for the Ventana MMR IHC panel, which was approved in 2017 to screen colorectal cancer patients for dMMR and Lynch syndrome.
 
Approval of Jemperli was based on efficacy findings in a cohort of the multicenter, multicohort, open-label GARNET trial. In all, 71 patients from the indicated population received the checkpoint inhibitor until disease progression or unacceptable toxicity. Confirmed overall response rate was 42.3%, with complete and partial response rates of 12.7% and 29.6%, respectively. Median duration of response was not reached; response lasted at least 6 months for 93.3% of patients (range: 2.6 to 22.4 months, at last assessment).
 
The indication received accelerated approval based on tumor response rate and durability of response. Continued approval for this indication will depend on findings on verification and description of clinical benefit in follow-up investigations.
 
This review used the real-time oncology review pilot program and the assessment aid. The application was granted priority review and breakthrough therapy designation.
 
Zynlonta cleared for treating relapsed/refractory large B-cell lymphoma
ADC Therapeutics’ Zynlonta (loncastuximab tesirine-lpyl) has been granted accelerated approval for adults with previously treated, relapsed or refractory large B-cell lymphoma.
 
Zynlonta’s approval was based on efficacy findings in the open-label, single-arm LOTIS-2 trial in 145 adults from the indicated population who received the study drug until disease progression or unacceptable toxicity. Overall and complete response rates were 48.3% and 24.1%, respectively. Median response duration was 10.3 months after a median follow-up of 7.3 months.
 
The indication was granted accelerated approval based on overall response rate. Continued approval for this indication will depend on findings on verification and description of clinical benefit in follow-up investigations.
 
This review used the assessment aid. The application was granted priority review and orphan drug designations.

 

 

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Tags: FDA, US

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