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NEWS

Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Shots:Daiichi Sankyo and Merck reported efficacy results for raludotatug deruxtecan (R-DXd) in patients with recurrent Pt.-resistant ovarian, primary peritoneal, or fallopian tube cancer from the P-II (dose-optimization) part of the REJOICE-Ovarian01 P-II/III studyAcross all doses (4.8 mg/kg, 5.6 mg/kg, and 6.4 mg/kg), ORR was 50.5% (n=107) as assessed by BICR, with 3 complete…
October 21, 2025

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NEWS

Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots:The EMA has received MAA of relacorilant for the treatment of Pt-resistant ovarian cancerMAA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & showed favorable safetyRelacorilant (PO) is a GR antagonist that is…
October 15, 2025

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NEWS

Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers 

Shots:The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with AvastinDesignation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…
September 16, 2025

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NEWS

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots:The US FDA has accepted NDA of relacorilant for the treatment of Pt-resistant ovarian cancer (PDUFA: Jul 11, 2026)NDA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & favorable safetyAdditionally, relacorilant (GR antagonist)…
September 11, 2025

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Abbvie
NEWS

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the Health Canada’s Approval to Treat Platinum-Resistant Ovarian Cancer

Shots:Health Canada has approved Elahere under priority review to treat FRα+, Pt-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatmentsApproval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT  in pts (n=453) to treat PROC expressing high levels of FRα, as determined using the Ventana…
September 4, 2025

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VIEWPOINTS

Unlocking Approval: John Hayslip from Verastem Oncology in an Illuminating Conversation with PharmaShots 

Shots: Did you know that more than 80 % of Low-grade Serous Ovarian Cancer (LGSOC) patients experience recurrence? The US FDA recently approved Verastem Oncology’s Avmapki Fakzynja Co-Pack, as the first ever treatment of patients with KRAS-mutated recurrent LGSOC In an illuminating dialogue exchange with PharmaShots, John Hayslip, CMO at Verastem Oncology, provides a detailed overview…
July 28, 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 cancerUTRxM1-18 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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Accent Theraoeutics
NEWS

Accent Therapeutics to Highlight Preclinical Data of ATX-559 and ATX-295 at AACR 2025

Shots:Accent Therapeutics to present preclinical data of ATX-559 (DHX9 inhibitor) & ATX-295 (KIF18A inhibitor) at AACR 2025Presentation will highlight ATX-559’s activity in cancers exhibiting genomic instability & replication stress in in vivo models, incl. dMMR/MSI-H colorectal & BRCA-altered triple-negative breast cancer, plus ATX-295’s activity in ovarian cancer & its relation with whole genome…
March 26, 2025

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Gradalis
NEWS

The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Shots:The US FDA has granted RMAT designation to Vigil (gemogenovatucel-T) as a maintenance therapy for newly diagnosed advanced Stage IIIb/IV HRP ovarian cancer pts with cTMB-H who achieved complete response post-debulking surgery & frontline Pt-based doublet CT Designation was backed by ongoing P-IIb (VITAL) trial assessing Vigil vs PBO showed improved RFS (1EP) in all…
February 6, 2025

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