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FDA Approvals Roundup: Breyanzi, Ukoniq, Libtayo

Posted 10 February 2021 | By Renee Matthews 

FDA Approvals Roundup: Breyanzi, Ukoniq, Libtayo

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New approvals
Breyanzi okayed for relapsed/refractory large B-cell lymphoma
Juno’s Breyanzi (lisocabtagene maraleucel) has been approved for previously treated adults with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B.  
 
Approval of the CD19-directed chimeric antigen receptor T-cell immunotherapy was based on findings in the single-arm, open-label, multicenter TRANSCEND trial in patients from the indicated population. Overall response rate (ORR) among the 192 patients evaluable for response was 73%, with a complete response (CR) rate of 54%. Median time to first response was one month.
 
In all, 104 patients achieved CR, of whom 65% and 62% had remission for least 6 months and 9 months, respectively. The estimated median duration of response (DoR) was not reached among the complete responders. Estimated median DoR in patients with partial response was 1.4 months.
 
The application was granted priority review as well as designations as a regenerative medicine advanced therapy, breakthrough therapy, and orphan drug.
 
Juno is a Bristol-Myers Squibb company.
 
Ukoniq nabs accelerated approval for two relapsed/refractory lymphomas
TG Therapeutics’ Ukoniq (umbralisib) has received accelerated approval for use in previously treated adults with relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL).
 
Approval of the kinase inhibitor was based on findings for two single-arm cohorts of an open-label, multicenter, multicohort UNITY-NHL trial. It included 69 patients with MZL who had received at least one previous treatment with an anti-CD20-based regimen, and 117 patients with FL who had received at least two previous systemic therapies. Participants received a once-daily, 800-mg oral dose of Ukoniq until disease progression or unacceptable toxicity. Overall response rate (ORR) in patients with MZL was 49%, with 16% achieving complete responses (CRs). Median duration of response (DoR) was not reached in this group. ORR in patients with FL was 43%, with 3% achieving CRs. Median DoR for the FL group was 11.1 months.
 
The review for this application used the assessment aid. The application received priority review for the MZL indication and orphan drug designation for treating MZL and FL. Both indications were granted accelerated approval based on the ORR. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
 
New indications
Libtayo gets expanded indications for locally advanced and metastatic BCC
Regeneron’s Libtayo (cemiplimab-rwlc) has been approved for previously treated patients with locally advanced basal cell carcinoma (laBCC) and granted accelerated approval for patients with metastatic BCC (mBCC). Both indications are for patients who have received previous hedgehog pathway inhibitor (HHI) therapy, or for whom an HHI is not appropriate.
 
Libtayo’s efficacy was evaluated in an ongoing open-label, multicenter, nonrandomized trial in patients from the indicated population. They received 350 mg Libtayo by intravenous infusion every 3 weeks for up to 93 weeks until disease progression, unacceptable toxicity, or treatment completion.
 
Confirmed objective response rate (ORR) in laBCC patients was 29%, with a median duration of response (DoR) not reached (range, 2.1 to ≥21.4 months). Among responders, 79% had a DoR of at least 6 months. In the 28 patients with mBCC, confirmed ORR was 21%, with a median DoR not reached (range, 9 to ≥23.0 months). All mBCC responders maintained their responses for at least 6 months.
 
The review for this application used the assessment aid. The application was granted priority review.
 
Libtayo was first approved in 2018 advanced cutaneous squamous cell carcinoma.
 

 
 

Tags: FDA, US

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