FDA Gives Accelerated Approval To Amgen's Drug For Small Cell Lung Cancer Patients

Thursday, the FDA approved Amgen Inc’s AMGN Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. 

Imdelltra has received accelerated approval based on the response rate and duration of response (DoR) observed in clinical studies. 

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Related: Amgen Outlook Is Bright, Analyst Predict Obesity-Focused Drug Potential Will Drive Shareholder Value.

“Less than 3% of patients with ES-SCLC live longer than five years,” said David Carbone, professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center. 

Imdelltra is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the patient’s T cells to attack DLL3-expressing tumor cells.

The FDA accelerated approval of Imdelltra is based on results from the Phase 2 DeLLphi-301 clinical trial that evaluated Imdelltra in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen. 

The study’s results found that Imdelltra at the 10 mg Q2W dose (N=99) demonstrated an objective response rate (ORR) of 40% and a median DoR of 9.7 months.

The median overall survival (mOS) was 14.3 months, with final and complete survival data yet to mature.

The Imdelltra label includes a Boxed Warning for cytokine release syndrome and neurologic toxicity.

Price Action: AMGN shares traded lower by 0.94% at $311.75 at last check Friday.

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