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TOP STORIES from the week

Tikva Allocell Secures $8 Million Series A Financing to Advance Engineered Off-the-Shelf Cell Therapies for Solid Tumors

Positive Updated Ph 2 Data and Expansion of Safusidenib Clinical Program with Two New Studies to Explore Broad Spectrum of IDH1-Mutant Glioma Announced 

Lupin spins out two oncology programs LNP7457 (PRMT5) and LNP8701 (SOS1) into Kaveri Therapeutics

First Patient Dosed With ITOP1 in clinical trial of solid tumors

TECVAYLI + TALVEY reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line R/R multiple myeloma

FDA Approves KEYTRUDA and KEYTRUDA QLEX each with Trodelvy as 1L Treatment of PD-L1+ (CPS ≥10) Advanced TNBC

FDA accepts NDA for Daraxonrasib for Review for Previously Treated Metastatic Pancreatic Cancer

TECVAYLI + TALVEY reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line R/R multiple myeloma

First Patient Dosed in Dose-Expansion Phase of STARLIGHT-1 Trial and Reports Durable Response Rate in Advanced B-Cell NHL

Lupin spins out two oncology programs LNP7457 (PRMT5) and LNP8701 (SOS1) into Kaveri Therapeutics

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Drug approvals

Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1L advanced ER-positive breast cancer

Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive NSCLC

FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

FDA approves SC Sarclisa (isatuximab-irfc) Escena + SOC for multiple myeloma patients across all existing indications of Sarclisa IV formulation

Regulatory news

Enhertu + pertuzumab recommended for approval in the EU by CHMP in 1L HER2-positive metastatic breast cancer

FDA accepts NDA for Daraxonrasib for Review for Previously Treated Metastatic Pancreatic Cancer

Supplemental Application accepted for Toripalimab + Chemo as Perioperative Treatment for Resectable Stage II-III NSCLC

CHMP Recommends Trodelvy + Keytruda in PD-(L)1+ve 1L Metastatic TNBC

Trial results

Positive Updated Ph 2 Data and Expansion of Safusidenib Clinical Program with Two New Studies to Explore Broad Spectrum of IDH1-Mutant Glioma Announced 

TECVAYLI + TALVEY reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line R/R multiple myeloma

Sonesitatug vedotin demonstrated statistically significant OS improvement in 2L+ CLDN18.2-positive advanced gastric/GEJ cancers

Confirmed Durable Partial Response in Ph 1 Trial of RAD204 in Patients with Advanced Solid Tumors Post-Immunotherapy

trial status

First Patient Dosed With ITOP1 in clinical trial of solid tumors

First Patient Dosed in Dose-Expansion Phase of STARLIGHT-1 Trial and Reports Durable Response Rate in Advanced B-Cell NHL

First Participant Dosed in Ph 1 Trial of mRNA-4200 in Solid Tumors

Enrollment completed in Ph 1 Dose Escalation Study of IPH4502 in patients with advanced solid tumors

Business news

Tikva Allocell Secures $8 Million Series A Financing to Advance Engineered Off-the-Shelf Cell Therapies for Solid Tumors

Lupin spins out two oncology programs LNP7457 (PRMT5) and LNP8701 (SOS1) into Kaveri Therapeutics

BeOne Medicines Expands U.S. Manufacturing with More Than $1 Billion Investment to Advance Cancer Medicines

Akari Therapeutics Enters Strategic Research Collaboration with Whitehawk Therapeutics

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