[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Notices]
[Page 19153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06576]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0964]


GlaxoSmithKline Intellectual Property Development Ltd. England; 
Announcement of the Revocation of the Biologics License for BLENREP

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the revocation of the biologics license for BLENREP (belantamab 
mafodotin-blmf) powder for injection. GlaxoSmithKline Intellectual 
Property Development Ltd. England (GSK) requested withdrawal 
(revocation) of the biologics license and has waived its opportunity 
for a hearing.

DATES: The biologics license application (BLA) is revoked as of 
February 6, 2023.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: On August 5, 2020, FDA approved the BLA for 
BLENREP (belantamab mafodotin-blmf) powder for injection held by 
GlaxoSmithKline Intellectual Property Development Ltd. England (GSK), 
c/o GlaxoSmithKline, 1250 South Collegeville Rd., Collegeville, PA 
19426, indicated for the treatment of adult patients with relapsed or 
refractory multiple myeloma who have received at least four prior 
therapies including an anti-CD38 monoclonal antibody, a proteasome 
inhibitor, and an immunomodulatory agent, under the Agency's 
accelerated approval regulations, 21 CFR part 601, subpart E. On 
November 2, 2022, FDA and GSK met to discuss the results of the 
confirmatory study required as a condition of BLENREP's accelerated 
approval, entitled ``Study of Single Agent Belantamab Mafodotin Versus 
Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants with 
Relapsed/Refractory Multiple Myeloma (DREAMM-3 trial)'' and 
considerations regarding withdrawal (revocation) of the biologics 
license for BLENREP because the confirmatory DREAMM-3 trial did not 
meet its primary endpoint to demonstrate superior progression-free 
survival. On November 18, 2022, GSK requested withdrawal (revocation), 
in writing, of the biologics license for BLENREP (belantamab mafodotin-
blmf) powder for injection (BLA 761158) under Sec.  601.5(a) (21 CFR 
601.5(a)) and waived its opportunity for a hearing. On February 6, 
2023, the Agency issued a letter to GSK revoking the biologics license 
for BLENREP (belantamab mafodotin-blmf) powder for injection (BLA 
761158).
    Therefore, under Sec.  601.5(a), the Agency revoked the biologics 
license for BLENREP (belantamab mafodotin-blmf) powder for injection 
(BLA 761158), effective as of February 6, 2023, the date of FDA's 
letter revoking the biologics license for BLENREP.

    Dated: March 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06576 Filed 3-29-23; 8:45 am]
BILLING CODE 4164-01-P