Shooting Cancer Highlights – Periodic focus on regulatory status of new targeted therapies in oncology

EMA

July 23 –  Inavolisib – BC PIK3CA. the European Commission has approved the mutant-selective PI3K? inhibitor, in combination with palbociclib and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.

 CHMP

July 24 –  Vorasidenib – LGG IDH1/2. 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 first-in-class dual isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor intended for the treatment of low grade astrocytoma or oligodendroglioma (subtypes of low-grade glioma, [LGG]) with an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adults and adolescents from 12 years of age weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy.

FDA

July 2 –  Sunvozertinib – NSCLC EGFR. The U.S. Food and Drug Administration (FDA) has approved the irreversible, and selective EGFR tyrosine kinase inhibitor for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

August 6 –  Dordaviprone – DMG H3K27M. The Food and Drug Administration (FDA) has granted accelerated approval for the dopamine receptor D2 (DRD2) antagonist for the treatment of adult and paediatric patients 1 year of age and older with diffuse midline glioma (DMG) harbouring an H3 K27M mutation with progressive disease following prior therapy.

August 8 –  Zongertinib – NSCLC HER2. The Food and Drug Administration (FDA) granted accelerated approval to the HER2 tyrosine kinase inhibitor for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

July 22 –  DB-1310– NSCLC EGFR. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310 for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

July 23 –  Elironrasib – NSCLC KRAS. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation the RAS(ON) G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received prior chemotherapy and immunotherapy, but have not been previously treated with a KRAS G12C inhibitor.

July 24 –  VS-7375 – PDAC KRAS. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the oral KRAS G12D (ON/OFF) inhibitor, for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy.

August 18 –  Iza-bren – NSCLC EGFR. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren), a bispecific antibody-drug conjugate (ADC) which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3) with a topoisomerase 1 inhibitor payload, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

August 28 –  TTI25-802 – NSCLC EGFR/KRAS. The inhibitor of CBP/p300 received two Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer (NSCLC). One Fast Track designation was granted for the treatment of patients with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R substitution mutation, with disease progression on at least one line of prior therapy including an EGFR inhibitor. The second Fast Track designation was granted for the treatment of patients with locally advanced or metastatic KRAS G12C mutated NSCLC, with disease progression on at least one line of prior therapy including a KRAS G12C inhibitor.

August 28 –  D3S-001– NSCLC/CRC KRAS. The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation to the next generation KRAS G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior chemotherapy and immunotherapy, but have not been previously treated with a KRAS G12C inhibitor. Additionally, D3S-001 has been granted Orphan Drug Designation for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).