GlaxoSmithKline Intellectual Property Development Ltd. England; Announcement of the Revocation of the Biologics License for BLENREP, 19153 [2023-06576]

Download as PDF 19153 Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices ‘‘shall set forth sufficient facts, including dates if possible, to merit an investigation by FDA of whether the applicant acted with due diligence.’’ Upon receipt of a due diligence petition, FDA reviews the petition and evaluates whether any change in the regulatory review period is necessary. If so, the corrected regulatory review period is published in the Federal Register. A due diligence petitioner not satisfied extension of approval is being sought is the use of the statutorily created due diligence petition. In the Federal Register of August 10, 2022 (87 FR 48667), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: with FDA’s decision regarding the petition may request, under § 60.40 (21 CFR 60.40), an informal hearing for reconsideration of the due diligence determination. Petitioners are likely to include persons or organizations having knowledge that FDA’s marketing permission for that product was not actively pursued throughout the regulatory review period. The information collection for which an TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Average burden per response Total annual responses Total hours Revision of regulatory review period determinations; § 60.24 .............................................................................. Due diligence petitions; § 60.30 ........................................... Due diligence hearings; § 60.40 .......................................... 4 1 1 1.25 1 1 5 1 1 100 50 10 500 50 10 Total .............................................................................. ........................ ........................ ........................ ........................ 560 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects an overall decrease of 34 hours and 11 responses. Since publication of the 60day notice, we have adjusted our burden estimate to reflect an annualized figure (reducing responses associated with § 60.24 by one-third), which results in a decrease to the currently approved burden. There is also a small adjustment decrease of one response associated with submissions received for revision of the regulatory review period determination under § 60.24 since our last review. Dated: March 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–06573 Filed 3–29–23; 8:45 am] BILLING CODE 4164–01–P 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. lotter on DSK11XQN23PROD with NOTICES1 Number of responses per respondent Number of respondents 21 CFR part 60—patent term restoration ACTION: Notice. 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 SUMMARY: VerDate Sep<11>2014 17:22 Mar 29, 2023 Jkt 259001 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, Kimberly.Lehrfeld@ fda.hhs.gov. 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 PO 00000 Frm 00103 Fmt 4703 Sfmt 9990 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 § 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 § 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 E:\FR\FM\30MRN1.SGM 30MRN1

Agencies

[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

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