[Federal Register Volume 87, Number 84 (Monday, May 2, 2022)]
[Notices]
[Pages 25644-25645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09235]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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DATES: Approval is withdrawn as of May 2, 2022.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, [email protected].

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