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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

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

China NMPA Approves TIVDAK® (tisotumab vedotin for injection) for the Treatment of Adult Patients with Recurrent or Metastatic Cervical Cancer

Serplulimab Approved by NMPA for Perioperative Gastric Cancer with tumour PD-L1 expression CPS ≥ 5, followed by adjuvant monotherapy

Regulatory news

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

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

TCX-001 approved by SwissMedic for First-in-Human Ph 1 trial in patients with R/R AML and CLL

FDA grants RMAT Designation to lasme-cel for Patients with R/R B-ALL

Trial results

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 

FAILED TRIAL: Ph 3 LAGOON trial of Zepzelca in patients with 2L SCLC did not meet primary endpoint of OS

FAILED TRIAL: Ph 2 AMPLIFY-7P trial did not meet the pre-specified primary endpoint of DFS in the ITT adjuvant pancreatic cancer population

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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