[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]
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