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TOP STORIES from the week

First Patients Dosed with ANOC-001 Targeting Mutant KRAS in Pancreatic Cancer

Updated clinical findings from GEP-NET patients treated with ¹⁷⁷Lu-DOTA-EB-TATE (EBTATE) announced

Azer-cel Granted FDA Fast Track Designation for CLL/SLL and MZL 

Sarclisa SQ approved in the EU as the first anticancer treatment administered via an on-body injector

GSK enters agreement to acquire Nuvalent, Inc.

FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each With WELIREG, for Adjuvant Treatment of Certain Patients With Clear Cell RCC

FDA cleared CTA for LILRB4/CD3 targeting TCE bispecific antibody (6MW5311) for the treatment of AML, CMML, and Multiple Myeloma

Ph 3 trial of Anbenitamab (KN026) + Docetaxel For Injection (Albumin-Bound) (HB1801) For 1L HER2+ve Advanced Breast Cancer Meets Primary Endpoint 

First Patient Enrolled in Ph 1b/2 Breast Cancer Study of AK138D1 Combined with Ivonescimab

IDEAYA Biosciences Announces Clinical Collaboration with Roche in MTAP-Deleted RAS-Mutant Pancreatic Cancer

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Drug approvals

Japan Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of R/R DLBCL Announced

Sarclisa subQ formulation approved in Japan for patients with multiple myeloma

Sarclisa SQ approved in the EU as the first anticancer treatment administered via an on-body injector

FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each With WELIREG, for Adjuvant Treatment of Certain Patients With Clear Cell RCC

Regulatory news

UAE IND Approval obtained for NEO212 Following Successful Ph 1 Completion, Advancing Toward Global Ph 2 Development

IND application for HLX3902 approved in China for treatment of metastatic CRPC and solid tumors

Positive Pre-IND Feedback from Received US FDA for CLD-401; IND enabling studies to continue with IND submission targeted by end of 2026

FDA grants Fast Track Designation for Ofirnoflast (HT-6184) in Lower-Risk MDS

Trial results

Multiple Complete Responses Reported After ELI-002 7P Treatment and Subsequent Therapy with Checkpoint Inhibition in Metastatic mKRAS Pancreatic Cancer

Ph 3 STELLAR-303 Trial of Zanzalintinib + Tecentriq in Metastatic CRC Patients didn’t meet the dual primary endpoint of OS improvement in the liver mets patients

Updated clinical findings from GEP-NET patients treated with ¹⁷⁷Lu-DOTA-EB-TATE (EBTATE) announced

Ph 3 trial of Anbenitamab (KN026) + Docetaxel For Injection (Albumin-Bound) (HB1801) For 1L HER2+ve Advanced Breast Cancer Meets Primary Endpoint 

trial status

First Patients Dosed with ANOC-001 Targeting Mutant KRAS in Pancreatic Cancer

First Patient Enrolled in Ph 1b/2 Breast Cancer Study of AK138D1 Combined with Ivonescimab

Second US Clinical Site Activated and Enrollment Opened for International Ph 2 THIO-101 Expansion Trial

Update Provided on Safety Profile of LYL273 in R/R Metastatic CRC and Ph 1 Trial Amended to Ph 1/2 Expansion

Business news

GSK enters agreement to acquire Nuvalent, Inc.

Recipharm and Fusix Biotech advance novel oncolytic virus platform

Parabilis Medicines Announces Closing of Upsized Initial Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

IDEAYA Biosciences Announces Clinical Collaboration with Roche in MTAP-Deleted RAS-Mutant Pancreatic Cancer

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