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NDA initiated with US FDA for TAR-200 for patients with BCG-unresponsive high-risk NMIBC

“Upon approval, TAR-200 promises to be a meaningful additional treatment option for certain patients with NMIBC, addressing a critical need for people who have had relatively limited therapeutic alternatives. Many patients face life-altering surgical options such as radical cystectomy, which is complete bladder removal,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Innovative Medicine. “By combining our expertise in innovative medicine and medical devices, Johnson & Johnson is uniquely positioned to transform how we treat certain types of bladder cancer through the first and only intravesical drug releasing system for this disease. We look forward to working with the FDA in review of this application.”

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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

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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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