FDA approves tepotinib for metastatic NSCLC with MET exon 14 skipping alterations
“The primary efficacy measures were ORR and DOR, determined by a Blinded Independent Review Committee. Among 164 treatment-naïve patients, ORR was 57% (95% CI: 49, 65), with 40% of responders having a DOR ≥12 months. Among 149 previously treated patients, ORR was 45% (95% CI: 37, 53), with 36% of responders having a DOR ≥12 months. The most common adverse reactions (≥20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.”
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“The start of patient dosing represents a huge milestone for Moleculin and importantly, the AML community,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Our team remains focused on bringing clinical sites online in the U.S., Europe and Middle East and enrolling patients to build on this momentum.
“Enrollment of the first patient with HPV+ head and neck cancer in the Phase 1 ACESOT-1051 trial is an important step and is in line with our goal of identifying patient populations most likely to benefit from WEE1 inhibition,” said Philippe Pultar MD., Senior Medical Advisor and Lead WEE1 Clinical
“We are thrilled to partner with Aurigene Oncology’s exceptional team, whose deep expertise in oncology development and cell therapy manufacturing is unparalleled,” said Michal Golan Mashiach, CEO of Edity Therapeutics. “This collaboration is a pivotal step in advancing our mission to deliver transformative, curative medicines to cancer patients.”
“We evaluate our clinical programs to focus our resources on the most promising clinically differentiated candidates while thoughtfully de-prioritizing others. Our commitment remains steadfast: to discover and develop innovative treatments that are more affordable and accessible to cancer patients worldwide,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors
