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TOP STORIES from the week

FDA Grants Fast Track Designation for TRE-515 in Combination with KRAS G12C Inhibitors for the Treatment of NSCLC

Ligand and AvenCell Therapeutics Enter Financing Agreement to Advance Pipeline of Next-Generation CAR-T Therapies for Up to $47 Million

First Patient Enrolled in Global Ph 3 Trial of Cadonilimab vs Nivolumab in 1L Gastric Cancer

Giredestrant combination significantly improved PFS in ER-positive advanced breast cancer in Ph 3 evERA; data published in The NEJM

FDA Clears IND Application for CR-002 for the Treatment of Solid Tumors

FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

FDA Clears IND Application for CR-002 for the Treatment of Solid Tumors

Epcoritamab + R-CHOP combo Demonstrates Significant PFS Improvement versus R-CHOP in 1L DLBCL Patients

First patient dosed in Ph 1/2 trial of ARV-6723 in advanced solid tumors

AstraZeneca, Daiichi Sankyo, and Summit Therapeutics to evaluate Datroway + ivonescimab combo across multiple tumour types

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Drug approvals

Jaypirca (pirtobrutinib) receives expanded indication from US FDA for 1L CLL/SLL patients

FDA Approves Lyrfigtu (Lirafugratinib) for 2L Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement Treatment Option

FDA approves BRAVNETSA™ (lutetium Lu 177 dotatate) for patients with SSR+ve GEP-NETs, including foregut, midgut, and hindgut NEC tumors

FDA Approves WELIREG + LENVIMA for Certain Previously Treated Adult Patients With clear cell RCC

Regulatory news

FDA Grants Fast Track Designation for TRE-515 in Combination with KRAS G12C Inhibitors for the Treatment of NSCLC

FDA Clears IND Application for CR-002 for the Treatment of Solid Tumors

NDA Submission Initiated for Zipalertinib + Chemo in 1L EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program

US NDA for ORPATHYS® plus TAGRISSO® in MET-Driven EGFR-Mutated Lung Cancer submitted

Trial results

Giredestrant combination significantly improved PFS in ER-positive advanced breast cancer in Ph 3 evERA; data published in The NEJM

Epcoritamab + R-CHOP combo Demonstrates Significant PFS Improvement versus R-CHOP in 1L DLBCL Patients

Results from VIRAGE Ph 2b Trial of VCN-01 in Metastatic Pancreatic Cancer Published in Nature Medicine

Positive topline results from Ph 3 AZTOUND trial of oral azacitidine and cedazuridine (ASTX030) in MDS and CMML patients announced 

trial status

First Patient Enrolled in Global Ph 3 Trial of Cadonilimab vs Nivolumab in 1L Gastric Cancer

First patient dosed in Ph 1/2 trial of ARV-6723 in advanced solid tumors

First patient dosed with LNK001 in Ph 1 study in patients with advanced or metastatic clear cell RCC

Second Patient treated in the Fifth Cohort of Ovarian Cancer FSHR-targeted CAR-T Clinical Trial

Business news

Ligand and AvenCell Therapeutics Enter Financing Agreement to Advance Pipeline of Next-Generation CAR-T Therapies for Up to $47 Million

AstraZeneca, Daiichi Sankyo, and Summit Therapeutics to evaluate Datroway + ivonescimab combo across multiple tumour types

Nurix Therapeutics Announces Second Research Term Extension for Oncology Program Under Collaboration with Gilead Sciences

United Immunity Announces Master Clinical Supply Agreement with Roche to Evaluate UI-102 + Anti–PD-L1 Therapy in Advanced Solid Tumors

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