Lutetium Lu177 Edotreotide

Amgen Launches Phase 3 Trials for Monthly Obesity Drug MariTide

3 months ago

• Amgen has initiated two pivotal Phase 3 trials of MariTide for obesity treatment, targeting both diabetic and non-diabetic populations with a three-tiered dosing strategy. • In previous Phase 2 trials, MariTide demonstrated approximately 20% weight loss over one year, though market reception was mixed regarding its competitive positioning. • The monthly dosing regimen of MariTide represents a potential differentiating factor in the increasingly competitive obesity drug market, with the company expressing confidence in the program's progression.

ITM-11 Demonstrates Superior Progression-Free Survival Compared to Everolimus in GEP-NETs

4 months ago

• ITM-11, a targeted radiopharmaceutical, significantly improved progression-free survival (PFS) in patients with Grade 1/2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). • The Phase 3 COMPETE trial marks the first time a radiopharmaceutical has shown superior PFS compared to everolimus in this patient population. • ITM plans to present the COMPETE data at an upcoming medical conference and discuss a potential New Drug Application (NDA) submission with the FDA in 2025. • The trial results support ITM-11's potential as a more effective treatment option for GEP-NETs, addressing a significant unmet need.

ITM-11 Radiopharmaceutical Achieves Phase III Success in GEP-NETs, Outperforming Everolimus

4 months ago

• ITM-11, a targeted radiopharmaceutical, demonstrated superior progression-free survival compared to everolimus in patients with grade 1-2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). • The Phase III COMPETE trial marks the first time a radiopharmaceutical has outperformed a molecular targeted therapy in a head-to-head study for GEP-NETs. • ITM-11 utilizes no-carrier-added Lutetium-177 to deliver targeted radiation to tumor cells expressing somatostatin receptors, minimizing damage to healthy tissue. • With a potential FDA submission in 2025, ITM-11 could become a frontrunner in radiopharmaceutical approvals, potentially boosting investment in the sector.

FDA Expands Enhertu Approval for Most Common Form of Breast Cancer

4 months ago

The FDA has approved Daiichi Sankyo and AstraZeneca's Enhertu for expanded use in patients with metastatic, hormone-positive breast cancer expressing low and ultra-low levels of HER2. This significant expansion covers treatment after hormone therapy for the most prevalent breast cancer type, potentially benefiting a broader patient population.

Datroway (Datopotamab Deruxtecan) Receives Global Approvals for Advanced Breast Cancer

5 months ago

• Datroway (Dato-DXd) gains first global approval in Japan for previously treated, unresectable, or recurrent HR-positive, HER2-negative breast cancer, offering a new alternative to conventional chemotherapy. • The FDA has approved Datroway for advanced breast cancer, marking the first U.S. approval for the antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo. • EMA endorsed Dato-DXd as a late-line option for certain breast cancer cases, adding to approvals in the U.S. and Japan and expanding treatment options in Europe. • Clinical trials, including TROPION-Breast01, demonstrated that Datroway significantly delayed cancer progression compared to standard chemotherapy, with manageable safety profiles.

FDA Approves Tevimbra Plus Chemotherapy for First-Line Treatment of Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA has approved Tevimbra (tislelizumab-jsgr) in combination with chemotherapy for first-line treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma with PD-L1 expression. • The approval was based on the RATIONALE-305 trial, which showed a median overall survival of 15.0 months with Tevimbra plus chemotherapy compared to 12.9 months with chemotherapy alone. • Common side effects of Tevimbra in combination with chemotherapy include decreased blood cell counts, fatigue, and gastrointestinal issues, but the combination offers a manageable safety profile. • This approval marks the second for Tevimbra in 2024, highlighting its potential to address critical needs in oncology and providing a valuable new treatment option.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

Grand Pharmaceutical's ITM-11 Phase III Trial Accepted for GEP-NETs in China

7 months ago

• Grand Pharmaceutical's ITM-11, a radionuclide-drug conjugate, has its Phase III clinical trial application accepted by China's NMPA. • The trial, named COMPETE Bridging Study, will evaluate ITM-11's efficacy and safety against standard therapy in GEP-NET patients. • ITM-11 targets somatostatin receptors on GEP-NET tumors, offering a potential new treatment option with improved radioisotope purity. • This trial, along with the ongoing COMPOSE trial, aims to address a broad spectrum of GEP-NET patients, where the incidence is increasing.

Lutetium Lu177 Edotreotide

Drug Development Updates