EMA

June 6 – Durvalumab – NSCLC EGFR/ALK. The European Commission (EC) has approved a Type II variation extension of indication to include the anti-PD-L1 antibody in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy after surgery, for the treatment of adults with resectable (tumours ? 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known EGFR mutations or ALK rearrangements.

 

CHMP

May 22 – Inavolisib – BC PIK3CA. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorisation for the PIK3CA inhibitor, in combination with palbociclib and fulvestrant, for the treatment of adults with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence on or within 12 months of completing adjuvant endocrine treatment.

FDA

May 8 – Avutometinib + Defactinib – LGSOC KRAS. The Food and Drug Administration (FDA) granted accelerated approval to the combination of avutometinib (dual RAF/MEK inhibitor) and defactinib (FAK inhibitor) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy.

June 11 – Taletrectinib – NSCLC ROS1. The Food and Drug Administration (FDA) has approved the next-generation oral ROS1 tyrosine kinase inhibitor for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

June 23 – Datopotamab deruxtecan– NSCLC EGFR. The Food and Drug Administration (FDA) granted accelerated approval to the TROP2 directed antibody drug conjugate for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

May 28 – Sevabertinib – NSCLC HER2. The Food and Drug Administration (FDA) has granted priority review to the HER2 tyrosine kinase inhibitor for the treatment of adult patients with advanced HER2-mutant non–small cell lung cancer (NSCLC), who have received prior systemic therapy.

June 1 – Ziftomenib – AML NMP1. The Food and Drug Administration (FDA) has granted priority review to the selective menin inhibitor for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML) harbouring an NPM1 mutation.

June 23 – Daraxonrasib – PDAC KRAS. The Food and Drug Administration (FDA) has granted breakthrough therapy designation to the multi-selective, tri-complex RAS(ON) inhibitor for the treatment of adult patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12X mutations.

June 24 – Revumenib– AML NMP1. The Food and Drug Administration (FDA) has granted priority review to the selective menin inhibitor for the treatment of adult patients with relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML).