Tarlatamab

Asher Bio partners with Amgen for a Phase 1b study combining etakafusp alfa and IMDELLTRA® in ES-SCLC patients. Etakafusp alfa, targeting CD8+ T cells, aims to enhance TCE efficacy by improving T cell function and tumor infiltration. The collaboration seeks to improve outcomes for ES-SCLC, a highly aggressive cancer with limited treatment options.

Asher Biotherapeutics partners with Amgen to evaluate etakafusp alfa combined with IMDELLTRA® in a global Phase 1b study for ES-SCLC. Etakafusp alfa targets CD8+ T cells to potentially enhance TCE efficacy. Asher Bio retains etakafusp alfa ownership, supplying it to Amgen at no cost.

The UK's MHRA granted conditional marketing authorization to tarlatamab for treating ES-SCLC patients post-platinum-based chemotherapy. The DeLLphi-301 study showed a 41% ORR and 9.7 months median DOR. Tarlatamab also received FDA approval, highlighting its potential as a novel treatment for ES-SCLC.

Starting January 1, 2025, Independence Blue Cross updates specialty drugs requiring precertification for certain plans. Includes FDA-approved drugs like Ahzantive, Bkemv, and pending approval drugs. Updates also reflect brand name changes for previously added drugs.

Amgen's Imdylltra (tarlatamab) received conditional MHRA approval for treating extensive-stage small cell lung cancer (ES-SCLC), marking a significant advancement. Approved for adults unresponsive to prior therapies, it showed a 41% response rate in trials. Despite promising efficacy, it carries risks like cytokine release syndrome and neurologic toxicity.

IMDYLLTRA® (tarlatamab) received UK MHRA conditional marketing authorisation for treating adult ES-SCLC patients post two prior therapies, including platinum-based chemotherapy. In a Phase 2 study, it showed a 41% objective response rate and 9.7-month median duration of response. SCLC, accounting for 15% of lung cancers, is aggressive with poor survival rates. Tarlatamab, a bispecific T-cell engager, targets DLL3 on tumor cells and CD3 on T cells, inducing tumor cell lysis. Common side effects include cytokine release syndrome and pyrexia.

Amgen’s Imdyllytra (tarlatamab) approved by MHRA for small cell lung cancer treatment in adults with advanced disease, showing a 40% response rate. Approved under Project Orbis, following US FDA approval. Amgen also received MHRA approval for Blincyto in acute lymphoblastic leukaemia.

Amgen Limited's tarlatamab (Imdyllytra) approved by MHRA for treating adult SCLC patients under Project Orbis, targeting cancer cells that divide rapidly. Approval granted on 31 December 2024, following prior treatment failures. MHRA emphasizes safety, quality, and efficacy standards are met.

The MHRA approved tarlatamab (Imdylltra) for treating adult SCLC patients under Project Orbis, allowing quicker cancer treatment approvals. Tarlatamab, an antineoplastic agent, is for patients unresponsive to two prior treatments. Administered intravenously, it showed a 40% response rate in trials. MHRA will monitor its safety and efficacy.