Positive CHMP Opinion for TEVIMBRA in Neoadjuvant/Adjuvant NSCLC Treatment
“TEVIMBRA is already approved in the EU across multiple settings in NSCLC, the most common form of lung cancer, and this positive CHMP opinion expands its potential to help patients earlier in their treatment journey,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. “As the foundational asset of our solid tumor portfolio, TEVIMBRA continues to demonstrate its strength and versatility across the continuum of care, bringing us closer to our goal of delivering more comprehensive and effective cancer treatment to more patients.”
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Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “HER2-directed therapies have already transformed care for certain HER2-expressing cancers, including breast and gastric cancers. However, many other cancers overexpress HER2, and targeted treatment options remain unavailable for most of these tumour types. This positive CHMP opinion underscores the importance
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The first patient was treated with [212Pb]VMT-α-NET in a fourth cohort of the Company’s ongoing Phase 1/2a clinical trial of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs). This cohort explores optimizing a 20 mCi cumulative dose by front-loading, with 6.0 mCi
“FDA Orphan Drug Designation for CLN-049 emphasizes both the urgent need for new therapies for people living with relapsed or refractory acute myeloid leukemia – including patients with TP53-mutated AML who currently face a particularly poor prognosis – and the potential of this FLT3-directed T cell engager to expand treatment