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BLA accepted for obecabtagene autoleucel (obe-cel) as a potential treatment for R/R Adult B-cell ALL

“Acceptance of the BLA filing is an important milestone for Autolus and we look forward to continuing our collaboration with the FDA during the review cycle,” commented Dr. Christian Itin, Chief Executive Officer of Autolus. “With the PDUFA date set for November, we remain focused on preparing for the potential launch of obe-cel.”

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Philochem AG Announces the Licensing of Worldwide Rights to OncoACP3 to RayzeBio, a BMS Company, for a potential value of up to $1.35B plus royalties

Prof. Dr. Dario Neri, CEO and CSO of Philogen, commented: “We are delighted to enter into this new collaboration with RayzeBio, a leader in the field of radiopharmaceutical medicines. This partnership will focus on the development and commercialization of OncoACP3 for both diagnostic and therapeutic applications in prostate cancer. OncoACP3

First patient dosed in DESTINY-Endometrial01 Ph 3 Trial of ENHERTU® Initiated as 1L Therapy in Patients with HER2 Expressing Primary Advanced or Recurrent Endometrial Cancer

“Following the positive results in the endometrial cancer cohort of DESTINY-PanTumor02, which contributed to a tumor agnostic approval for previously treated patients with HER2 positive metastatic tumors in several regions, we are initiating this first phase 3 trial of ENHERTU in the first-line setting of advanced endometrial cancer,” said Mark

Ph 3 KEYNOTE-B96 Trial Met PFS Primary Endpoint in Platinum-Resistant Recurrent Ovarian Cancer Patients Whose Tumors Expressed PD-L1 and in All Comers

“This marks the first time a KEYTRUDA-based regimen has shown the ability to help certain patients with platinum-resistant ovarian cancer live longer, and the first time an immune checkpoint inhibitor-based regimen has demonstrated an overall survival benefit in ovarian cancer,” said Dr. Gursel Aktan, vice president, global clinical development, Merck

Zepzelca® (lurbinectedin) and Tecentriq Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage SCLC

“The FDA’s Priority Review designation for Zepzelca in combination with atezolizumab as a first-line maintenance treatment highlights the urgent need for new approaches and the potential benefit of Zepzelca for patients with extensive-stage small cell lung cancer, a disease with limited therapeutic options and high unmet need,” said Rob Iannone,

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