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NEWS

Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved OncoMate MSI Dx Analysis System as a companion diagnostic to identify pts with microsatellite stable endometrial carcinoma The OncoMate MSI Dx Analysis System is a PCR-based assay that determines MSI status in tumors to identify pts eligible for treatment with Keytruda (pembrolizumab) & Lenvima (lenvatinib) OncoMate MSI Dx Analysis System…
5 days ago

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors

Shots: The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) to treat previously treated adults with HER2+ (IHC 3+) unresectable or metastatic solid tumors, who have unsatisfactory alternative treatment options MAA was supported by 3 P-II (DESTINY-PanTumor02, DESTINY-CRC02 & DESTINY-Lung01) trials, where DESTINY-PanTumor02 (n=267, incl. 111 HER2+ pts) assessed Enhertu (5.4mg/kg)…
September 11, 2025

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NEWS

Agilent Technologies Reports the US FDA’s Approval of MMR IHC Panel pharmDx (Dako Omnis) as a Companion Diagnostic Test for Colorectal Cancer

Shots: Agilent Technologies has received the US FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic (CDx) test for colorectal cancer Agilent & BMS partnered to develop the MMR IHC Panel pharmDx (Dako Omnis) to identify dMMR colorectal cancer pts eligible for Opdivo monotx. or Opdivo + Yervoy treatment The…
August 21, 2025

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Verastem Oncology New
NEWS

Verastem Oncology Reports First Patient Dosing with VS-7375  in P-I/IIa Study for KRAS G12D Advanced Solid Tumors

Shots: Verastem reported the dosing of the first patient (US) for P-I/IIa study (VS-7375-101) assessing the safety, tolerability, and efficacy of VS-7375 The dose-escalation phase of the study starts at 400mg, based on results from a P-I/II study conducted by GenFleet in China, and presented initial safety and efficacy data at ASCO’25 Upon reaching the…
June 25, 2025

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UTR Therapeutics
NEWS

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots: The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancer UTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…
May 9, 2025

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Personalis
NEWS

Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC)

Shots: Personalis has reported interim VICTORI study data assessing its NeXT Personal assay for the detection of early residual or recurrent CRC via ctDNA using blood samples from 71 pts with resectable Stage I-IV CRC At 15.75mos. mFU, 100% pts with recurrences, incl. distant metastases, were detected via ctDNA before imaging, with 87% detected within…
April 29, 2025

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NEWS

Agenus Highlights Data from Five Studies of Botensilimab/Balstilimab (BOT/BAL) Regimen as Multiple lines of Therapy in Colorectal Cancer at ASCO GI 2025

Shots: P-II neoadj. studies were UNICORN (n=56) & NEST (n=24) in resectable CRC. UNICORN: 93% & 29% pCR with 100% & 36% pMR in dMMR/MSI-H & pMMR/MSS tumors, respectively; NEST: At 18 (NEST-1) & 9mos. (NEST-2) follow-up, all were ctDNA-ve w/o recurrences; pMR improved to 47% in MSS tumors in NEST-2 P-I/II study of BOT/BAL…
January 23, 2025

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PharmaShots Interview Guardant Health’s Kathryn Lang Shares Insight on SHIELD Blood Test for Colorectal Cancer
VIEWPOINTS

PharmaShots Interview: Guardant Health’s Kathryn Lang Shares Insight on SHIELD Blood Test for Colorectal Cancer

In an interview with PharmaShots, Kathryn Lang, Vice President, Outcomes & Evidence at Guardant Health shared her views on the enrolment of the final patient in the (ECLIPSE) trial for SHIELD blood test to treat Colorectal Cancer Shots: The company has reported the patient enrolment in the (ECLIPSE) trial to evaluate SHIELD blood test in 12750 patients aged 45-84yr. with colorectal…
March 9, 2022

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