FDA Grants Accelerated Approval to Lurbinectedin for Metastatic Small Cell Lung Cancer

June 16, 2020

On June 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval (https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer) to lurbinectedin (Zepzelca™) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

FDA Grants Accelerated Approval to Lurbinectedin for Metastatic Small Cell Lung Cancer

Efficacy was demonstrated in the PM1183-B-005-14 trial (Study B-005; NCT02454972), a multicenter, open-label, multicohort study enrolling 105 patients with metastatic SCLC who had disease progression on or after platinum-based chemotherapy. Patients received lurbinectedin 3.2 mg/m2 by IV infusion every 21 days until they experienced disease progression or unacceptable toxicity.

The main efficacy outcome measures were confirmed overall response rate (ORR), determined by investigator assessment using response evaluation criteria in solid tumors 1.1, and response duration. Among the 105 patients, ORR was 35% (95% CI = 26%, 45%), with a median response duration of 5.3 months (95% CI = 4.1, 6.4). ORR per independent review committee was 30% (95% CI = 22%, 40%) with a median response duration of 5.1 months (95% CI = 4.9, 6.4).

The most common adverse reactions (≥ 20%), including laboratory abnormalities, were myelosuppression, fatigue, increased creatinine, increased alanine aminotransferase, increased glucose, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium, and diarrhea.

The recommended lurbinectedin dose is 3.2 mg/m2 every 21 days.

View full prescribing information for lurbinectedin (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf).

FDA gave the indication accelerated approval based on ORR and duration of response. Continued approval for the indication may be contingent on verification and description of clinical benefit in confirmatory trials.

FDA conducted the review under Project Orbis (https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis), an initiative of its Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For the application, a modified Project Orbis was undertaken because of the timing of submission to other regulatory agencies. FDA collaborated with Australia’s Therapeutic Goods Administration (TGA). FDA approved the application two months ahead of its goal date; the application review is ongoing for TGA.

FDA granted lurbinectedin orphan drug designation for the treatment of SCLC and priority review to the application. A description of FDA expedited programs is in the Guidance for Industry—Expedited Programs for Serious Conditions-Drugs and Biologics (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics).

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.   

For assistance with single-patient oncology investigational new drug applications, contact the Oncology Center of Excellence’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).   

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