EMA

  •  July 19 – Trastuzumab deruxtecan – BC HER2. The European Commission approved the HER2-directed antibody drug conjugate as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

CHMP

  • July 21 – Nivolumab/relatlimab – melanoma PD-L1. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the two monoclonal antibodies combination (a programmed death-1 inhibitor (anti-PD-1) and a lymphocyte-activation gene-3 inhibitor (anti-LAG-3) respectively) for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%.
  • July 21 – Selpercatinib – MTC RET. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an extension of indication for the treatment of advanced RET mutant medullary thyroid cancer. According to the CHMP opinion, the RET inhibitor as monotherapy would be indicated for the treatment of adults and adolescents 12 years and older with advanced RET mutant medullary thyroid cancer (MTC) in general and not limited to those patients who require systemic therapy following prior treatment with cabozantinib and/or vandetanib.

FDA

  • July 14 . Crizotinib – IMT ALK. The FDA approved the ALK TKI inhibitor for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).
  • July 25 – Trastuzumab deruxtecan – BC HER2. The FDA has accepted and granted Priority Review to the HER2 directed ADC for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received 1 prior therapy in the metastatic setting.
  • July 21 – OP-1250 – BC HR/HER2. The FDA has granted Fast Track Designation to the novel, oral complete estrogen receptor (ER) antagonist and selective ER degrader (SERD) for the treatment of patients with HR-positive HER2-negative metastatic breast cancer (mBC) that has progressed following 1 or more lines of endocrine therapy with at least 1 line given in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor.
  • July 6 – PBI-200 – solid tumours NTRK. The FDA has granted an Orphan Drug Designation to the TRK inhibitor for the treatment of patients with NTRK fusion–positive solid tumors, including primary and metastatic brain tumors.