Notice2022-09235
Acrotech Biopharma LLC; Withdrawal of Approval of New Drug Application for MARQIBO (VinCRIStine Sulfate LIPOSOME Injection), 5 milligrams/5 milliliters
Primary source
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Published
May 2, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for MARQIBO (vinCRIStine sulfate LIPOSOME injection), 5 milligrams (mg)/5 milliliters (mL), held by Acrotech Biopharma LLC (Acrotech), 29 Princeton Hightstown Rd., East Windsor, NJ 08520. Acrotech has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Full Text
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<title>Federal Register, Volume 87 Issue 84 (Monday, May 2, 2022)</title>
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[Federal Register Volume 87, Number 84 (Monday, May 2, 2022)]
[Notices]
[Pages 25644-25645]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0354]
Acrotech Biopharma LLC; Withdrawal of Approval of New Drug
Application for MARQIBO (VinCRIStine Sulfate LIPOSOME Injection), 5
milligrams/5 milliliters
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of new drug application (NDA) for MARQIBO
(vinCRIStine sulfate LIPOSOME injection), 5 milligrams (mg)/5
milliliters (mL), held by Acrotech Biopharma LLC (Acrotech), 29
Princeton Hightstown Rd., East Windsor, NJ 08520. Acrotech has
voluntarily requested that FDA withdraw approval of this application
[[Page 25645]]
and has waived its opportunity for a hearing.
DATES: Approval is withdrawn as of May 2, 2022.
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, <a href="/cdn-cgi/l/email-protection#8fc4e6e2edeafde3f6a1c3eae7fde9eae3ebcfe9ebeea1e7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="7e3517131c1b0c120750321b160c181b121a3e181a1f5016160d50191108">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On August 9, 2012, FDA approved NDA 202497
for MARQIBO (vinCRIStine sulfate LIPOSOME injection), 5 mg/5 mL, for
the treatment of adult patients with Philadelphia chromosome-negative
(Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse
or whose disease has progressed following two or more anti-leukemia
therapies, under the Agency's accelerated approval regulations, 21 CFR
part 314, subpart H. The accelerated approval of MARQIBO (vinCRIStine
sulfate LIPOSOME injection) for Ph-ALL included a required
postmarketing clinical trial intended to verify the clinical benefit of
MARQIBO (vinCRIStine sulfate LIPOSOME injection).
On September 24, 2021, FDA published the Federal Register notice
``Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment
of a Public Docket; Request for Comments,'' announcing that MARQIBO
(vinCRIStine sulfate LIPOSOME injection) would be discussed at an
Oncologic Drug Advisory Committee Meeting (ODAC) scheduled for December
2, 2021 (86 FR 53067). On October 27, 2021, FDA met with Acrotech to
discuss the planned ODAC meeting. At that meeting, the Agency
recommended the applicant voluntarily request withdrawal of approval
for MARQIBO (vinCRIStine sulfate LIPOSOME injection), 5 mg/5mL, due to
the lack of verification of clinical benefit. The postmarketing trial
required to verify clinical benefit had not been completed, and patient
recruitment to fulfill the PMR appeared to be significantly challenging
due to the treatment options that are currently available.
On November 19, 2021, Acrotech submitted a letter asking FDA to
withdraw approval of NDA 202497 for MARQIBO (vinCRIStine sulfate
LIPOSOME injection), 5 mg/5mL, pursuant to Sec. 314.150(d) (21 CFR
314.150(d)) and waiving its opportunity for a hearing. On November 23,
2021, FDA acknowledged Acrotech's request for withdrawal of approval of
the NDA and waiver of its opportunity for hearing. FDA also cancelled
the ODAC meeting scheduled for December 2, 2021, since Acrotech's
withdrawal request made discussion at an advisory committee meeting
moot.
For the reasons discussed above, and in accordance with the
applicant's request, approval of NDA 202497 for MARQIBO (vinCRIStine
sulfate LIPOSOME injection), 5 mg/5mL, and all amendments and
supplements thereto, is withdrawn under Sec. 314.150(d). Distribution
of MARQIBO (vinCRIStine sulfate LIPOSOME injection) 5 mg/5mL, into
interstate commerce without an approved application is illegal and
subject to regulatory action (see sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Dated: April 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09235 Filed 4-29-22; 8:45 am]
BILLING CODE 4164-01-P
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