EMA

  • February 28. Vandetanib – MTC RET. The European Commission has restricted the indication of the multi-tyrosin kinase inhibitor: it can be used exclusively to treat RET mutant medullary thyroid cancer (MTC) patients with unresectable locally advanced or metastatic disease.

Vandetanib should not be administered to patients in whom rearranged during transfection (RET) mutation status is not known or is negative.

Prior to initiation of treatment with vandetanib, the presence of a RET mutation should be determined by a validated test.

CHMP

  • February 23. Niraparib/abiraterone acetate – mCRPC BRCA 1/2. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for niraparib/abiraterone acetate to treat metastatic castration-resistant prostate cancer (mCRPC) with BRCA 1/BRCA 2 mutations.
  • February 23. Ivosidenib – AML/CCA IDH1. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ivosidenib for the treatment of newly diagnosed acute myeloid leukaemia (AML) with an IDH1 R132 mutation who are not eligible to receive standard induction chemotherapy and for the treatment of locally advanced or metastatic cholangiocarcinoma (CCA) with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
  • February 23. Cemiplimab – NSCLC PD-L1/EGFR/ALK/ROS1. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for cemiplimab in combination with platinum-based chemotherapy. Specifically, the CHMP recommended the cemiplimab combination be approved in the European Union for first-line treatment of adult patients with metastatic or locally advanced non-small cell lung cancer (NSCLC) expressing PD-L1 (in ? 1% of tumour cells) and with no EGFR, ALK or ROS1 aberrations and who are not candidates for definitive chemoradiation.

FDA

  • February 3. Sacituzumab govitecan – BC HR/HER2. The Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer, who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
  • February 9. Dostarlimab – EC MMR. The Food and Drug Administration (FDA) converted accelerated to regular approval of indication for dostarlimab-gxly for treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
  • March 3. Abemaciclib – BC HR/HER2. The Food and Drug Administration (FDA) approved abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
  • March 16. Dabrafenib + trametinib – LGG BRAF. The Food and Drug Administration (FDA) approved dabrafenib with trametinib for paediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
  • March 29. Pembrolizumab – solid tumours MMR/MSI. The Food and Drug Administration (FDA) converted to full approval indication for pembrolizumab for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
  • March 14. Ripretinib – GIST KIT. The Food and Drug Administration (FDA) has granted a breakthrough therapy designation (BTD) to ripretinib for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumour (GIST) who received prior treatment with imatinib and harbour a KIT exon 11 mutation and co-occurring KIT exon 17 and/or 18 mutations. Ripretinib is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases. Ripretinib inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. Ripretinib also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.