Oncology Updates - Key Oncology News

September 2nd Week, 2025

Regulatory Events

🎯 The US FDA approved Johnson & Johnson Innovative Medicine's INLEXZO (TAR-200; gemcitabine intravesical system) for the Tx of adults with BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors (Ref 1)

❓ How is this approval expected to impact the Tx paradigm?

🎯 The US FDA accepted Corcept Therapeutics' NDA for relacorilant (selective glucocorticoid receptor antagonist) as a Tx for patients with platinum-resistant ovarian cancer. (Ref 2)

❓ What are the other available Tx options for this indication?

🎯 The EMA validated the Type II Variation marketing authorization application for Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan (HER2 ADC) for the Tx of adults with HER2 +ve, unresectable or metastatic solid tumors who have received prior Tx and have no satisfactory alternative Tx options. (Ref 3)

❓ What are the clinical outcomes that support the MAA validation?

🎯 China's NMPA accepted the NDA for Alphamab Oncology and CSPC Pharmaceutical Group 's anbenitamab (anti-HER2 BsAb) + chemotherapy for the Tx of HER2 +ve, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior systemic therapy which must include trastuzumab + chemotherapy. (Ref 4)

❓ What is the development status of the regimen in other key geographies?

Clinical Events 

🔬 Johnson & Johnson Innovative Medicine announced positive topline results for OS from the Asia cohort of the Phase 3 MARIPOSA trial of amivantamab (EGFR x MET BsAb) + lazertinib (tyrosine kinase inhibitor) as a first-line Tx for patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations. (Ref 5)

❓ How is this readout expected to impact the OS benchmarks for this indication?

Special Designations

⭐ The US FDA granted the Orphan Drug Designation to Beyond Air®'s BA-101 (nitric oxide synthase inhibitor) for the Tx of Glioblastoma. (Ref 6)

❓ What are the key unmet medical needs of this indication?

⭐ The US FDA granted the Fast Track Designation to Greenwich LifeSciences' GLSI-100 (GP2 + GM-CSF) for the Tx of patients with HLA-A*02 genotype and HER2+ve breast cancer who have completed Tx with standard of care HER2/neu targeted therapy. (Ref 7)

❓ Which other regimens have received the fast track designation for this indication?

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