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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 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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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 2025 Presentation 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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Abbvie
NEWS

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

    Shots:    The EC has approved Elahere to treat FRα+, Pt-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments, valid across whole EU plus Iceland, Liechtenstein, Norway & Northern Ireland  Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT (weekly paclitaxel, pegylated liposomal…
November 18, 2024

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NEWS

AbbVie Reports the CHMP’s Positive Opinion of Elahere (Mirvetuximab Soravtansine) to Treat Ovarian Cancer 

      Shots:    The CHMP has granted positive opinion to Elahere for treating FRα+, Pt-resistant & high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer in adults who have received 1 to 3 prior therapies. The decision is anticipated in Q4’24, with other reviews underway  The opinion was based on P-III (MIRASOL) study assessing Elahere…
September 20, 2024

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Viewpoints_Jane Chung
VIEWPOINTS

Expanding ADC Therapy: Jane Chung from Sutro Biopharma in an Engaging Conversation with PharmaShots

Shots:   Luvelta, an antibody-drug conjugate by Sutro Biopharma is designed to target FRα, expressed in ovarian cancer, developed and manufactured using the company’s proprietary cell-free technology, XpressCF   Today, at PharmaShots, we have Jane Chung, President and CEO at Sutro Biopharma, shedding on the ongoing REFRαME-O1 study evaluating luvelta   Sutro is now enrolling patients for the…
July 24, 2024

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VIEWPOINTS_Andrea Mugan1_2023
VIEWPOINTS

Andrea Mugan, Global Franchise Head of DDR & GYN/GU Cancers, AstraZeneca Shares Insights from the Launch of Digital Patient Support Resource for Ovarian Cancer Patients

Shots:  Andrea talked about the launch of a digital patient support resource by the Ovarian Cancer Commitment (OCC) in co-development with AstraZeneca and other organizations for ovarian cancer patients  She also highlighted how this important resource, named Olivia supports in navigating ovarian cancer diagnosis. This tool is an interactive tool that allows users to access…
March 16, 2023

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