sBLA and NDA submitted for RYBREVANT® (amivantamab-vmjw) + Lazertinib for the Treatment of Patients with EGFR-Mutated NSCLC
“The combination of RYBREVANT® and lazertinib demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to osimertinib in patients with previously untreated EGFR-mutated NSCLC. This remains an area of high unmet need as patients often experience treatment resistance and disease progression on currently available therapies,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine. “We believe this targeted, chemotherapy-free regimen may have the potential to transform the treatment of EGFR-mutated NSCLC, and we look forward to working with the FDA in review of these applications.”
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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
