2024-06298. AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of New Drug Application for LYNPARZA (Olaparib) Capsules

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 LYNPARZA (olaparib) Capsules, 50 milligrams (mg) held by AstraZeneca Pharmaceuticals LP (AZ), 1800 Concord Pike, Wilmington, DE 19803. AZ has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.

DATES:

Approval is withdrawn as of March 26, 2024.

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, [e-mail].

SUPPLEMENTARY INFORMATION:

On December 19, 2014, FDA approved NDA 206162 for LYNPARZA (olaparib) Capsules, 50 mg, as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. On July 14, 2022, FDA met with AZ to discuss the final overall survival (OS) results from the clinical trial entitled “A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations” (SOLO3).” ^[1] The results indicated that patients who were taking olaparib potentially had a shorter OS than patients not on olaparib, particularly in the subgroup analysis of patients who had received three or more lines of chemotherapy. On July 26, 2022, the Agency asked AZ, in writing, to voluntarily permit FDA to withdraw approval of NDA 206162, pursuant to § 314.150(d) (21 CFR 314.150(d)) and waive its opportunity for a hearing for NDA 206162. On January 19, 2023, AZ submitted a letter requesting withdrawal of approval of the application for LYNPARZA (olaparib) Capsules (NDA 206162) pursuant to § 314.150(d) and waiving its opportunity for a hearing.

Approval of NDA 206162 for LYNPARZA (olaparib) Capsules, and all amendments and supplements thereto, is also withdrawn under § 314.150(d) as of March 26, 2024. Distribution of LYNPARZA (olaparib) Capsules, 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: March 15, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  The study, under its abbreviated title “Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments (SOLO3),” is available on the NIH National Library of Medicine's ClinicalTrials.gov web page at https://clinicaltrials.gov/​ct2/​show/​NCT02282020.