Document ID: FDA-2020-N-1618-0001
Agency: fda
Document Type: Notice
Title: Eli Lilly and Co.; Announcement of the Revocation of the Biologics License
for LARTRUVO
Posted Date: 2020-07-17T04:00Z

[Federal Register Volume 85, Number 138 (Friday, July 17, 2020)]
[Notices]
[Page 43587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15516]

[[Page 43587]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1618]

Eli Lilly and Co.; Announcement of the Revocation of the 
Biologics License for LARTRUVO

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 application (BLA) for LARTRUVO 
(olaratumab) injection. Eli Lilly and Co. requested withdrawal 
(revocation) of the biologics license application and has waived its 
opportunity for a hearing.

DATES: The BLA is revoked as of February 25, 2020.

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.

SUPPLEMENTARY INFORMATION: On October 19, 2016, FDA approved the BLA 
for LARTRUVO (olaratumab) injection held by Eli Lilly and Co. (Eli 
Lilly), Lilly Corporate Center, Indianapolis, IN 46285, indicated, in 
combination with doxorubicin, for the treatment of adult patients with 
soft tissue sarcoma with a histologic subtype for which an 
anthracycline-containing regimen is appropriate and which is not 
amenable to curative treatment with radiotherapy or surgery, under the 
Agency's accelerated approval regulations at 21 CFR part 601, subpart 
E. On January 18, 2019, Eli Lilly reported in a press release that the 
confirmatory study required as a condition of LARTRUO's accelerated 
approval, entitled ``Randomized, Double-Blind, Placebo-Controlled, 
Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus 
Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma'' 
(ANNOUNCE trial), ``did not meet the primary endpoints of overall 
survival in the full study population or in the leiomyosarcoma 
subpopulation.'' On September 27, 2019, Eli Lilly requested withdrawal 
(revocation), in writing, of the BLA for LARTRUVO (olaratumab) 
injection (BLA 761038) under Sec.  601.5(a) (21 CFR 601.5(a)) because 
the ANNOUNCE trial failed to demonstrate improvement in overall 
survival for olaratumab in combination with doxorubicin compared to 
doxorubicin alone. In that letter, Eli Lilly waived its opportunity for 
a hearing. On February 25, 2020, the Agency issued a letter to Eli 
Lilly revoking the approval to manufacture and market LARTRUVO 
(olaratumab) injection (BLA 761038).
    Therefore, under Sec.  601.5(a), the Agency revoked the BLA for 
LARTRUVO (olaratumab) injection (BLA 761038), applicable as of February 
25, 2020.

    Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15516 Filed 7-16-20; 8:45 am]
BILLING CODE 4164-01-P