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TOP STORIES from the week

FDA provides Feedback in Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

First Patient dosed in Ph 3 RASolve 308 Trial of Zoldonrasib + Pembrolizumab and Chemo in 1L Metastatic RAS G12D Non-Squamous NSCLC

Georgiamune and Menarini Group Enter Exclusive Global License and Collaboration Agreement for GIM-621

First Patients enrolled in Standard of Care Chemo Combination Cohorts of Global Ph 1/2 ASCEND Trial of CR-001

FDA approves TALZENNA plus XTANDI for HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer

European Commission approves TECVAYLI (teclistamab) monotherapy for relapsed/refractory multiple myeloma

FDA grants Fast Track Designation for MC001 for Pancreatic Cancer

Data from FURTHER Ph 1b (FURMO-002) of firmonertinib in 1L EGFR PACC-mutant NSCLC published in Cancer Cell

First Patients enrolled in Standard of Care Chemo Combination Cohorts of Global Ph 1/2 ASCEND Trial of CR-001

Zymeworks Enters into an Exclusive Global License and Collaboration Agreement with Roche for ZW209

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Drug approvals

FDA approves TALZENNA plus XTANDI for HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer

European Commission approves TECVAYLI (teclistamab) monotherapy for relapsed/refractory multiple myeloma

FDA grants traditional approval for Keytruda or Keytruda Qlex for unresectable or metastatic TMB-H solid tumors with updated indication

European Commission Approves KEYTRUDA® + Padcev® as Perioperative Treatment for Adults With Resectable MIBC

Regulatory news

FDA provides Feedback in Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

FDA grants Fast Track Designation for MC001 for Pancreatic Cancer

CHMP recommends approval of TALVEY® (talquetamab) plus daratumumab in earlier line treatment of relapsed/refractory multiple myeloma

New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) accepted for review by the China NMPA

Trial results

Rinatabart Sesutecan (Rina-S®) Demonstrates Statistically Significant Improvement in PFS and OS in Patients with Platinum-Resistant Ovarian Cancer

VS-7375 Demonstrates 50% Confirmed ORR in 2L Pancreatic Ductal Adenocarcinoma and Two Complete Responses in 2L+ Disease (One Confirmed)

Data from FURTHER Ph 1b (FURMO-002) of firmonertinib in 1L EGFR PACC-mutant NSCLC published in Cancer Cell

Positive Ph 2 Final Efficacy Results from Investigator-Sponsored TASKIN Trial in Refractory Metastatic CRC Announced

trial status

First Patient dosed in Ph 3 RASolve 308 Trial of Zoldonrasib + Pembrolizumab and Chemo in 1L Metastatic RAS G12D Non-Squamous NSCLC

First Patients enrolled in Standard of Care Chemo Combination Cohorts of Global Ph 1/2 ASCEND Trial of CR-001

Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Advances to Expansion Stage in Phase II First-Line Gastric Cancer Study

University of California, Davis activated as a Clinical Trial Site for Ongoing Ph 1 CERTAIN-T Trial of CER-1236 in Hematologic Malignancies

Business news

Georgiamune and Menarini Group Enter Exclusive Global License and Collaboration Agreement for GIM-621

Zymeworks Enters into an Exclusive Global License and Collaboration Agreement with Roche for ZW209

Genmab and Incyte Announce Clinical Trial Collaboration in Metastatic CRC

Akeso Announces Summit Therapeutics and ECOG-ACRIN Cancer Research Group Enter into Ph 2/3 Clinical Trial Collaboration to Evaluate Ivonescimab in 1L BTC

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