The US FDA Accepts Amgen's BLA for Tarlatamab and Granted Priority Review for Advanced Small Cell Lung Cancer
Shots:
- The BLA was submitted based on the results from the P-II (DeLLphi-301) clinical trial evaluating tarlatamab (10mg & 100mg, Q2W) patients (N=220) with advanced SCLC in 2 cohorts with median follow up of either 10.6mos. (10mg) or 10.3mos. (100mg). The assigned PDUFA date for tarlatamab is Jun 12, 2024
- The results from the trial showed among patients evaluable for antitumor activity & survival (n=68), OR occurred in 40% (10mg) & 32% (100mg), DoR of 6mos. in 59%, mPFS of 4.9mos. & 3.9mos. whereas OS at 9mos. was depicted in 68% & 66% of the patients4
- Tarlatamab is an investigational DLL3 targeting BiTE therapy developed by Amgen as a targeted therapy for SCLC. Earlier in Oct 2023, the US FDA also granted a BTD to tarlatamab
Ref: Amgen | Image: Amgen
Related News:- Q32 Bio Signs an Agreement with Amgen to Retrieve the Rights to Bempikibart (ADX-914) for Autoimmune Diseases
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
