Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jul 3
- 2 min read
Updated: Jul 4
02/07/2025
Lynozyfic received accelerated approval from the US FDA for R/R Multiple Myeloma (Ref)
Regeneron Pharmaceuticals announced that the US FDA granted accelerated approval for linvoseltamab-gcpt (Lynozyfic; BCMA x CD3 bispecific antibody) for patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody
The accelerated approval was granted based on results from the Phase 1/2 LINKER-MM1 trial in which an ORR of 70% and CR of 45% was achieved in heavily pre-treated multiple myeloma patients
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
To note, the prescribing information for linvoseltamab has a boxed warning for cytokine release syndrome and neurologic toxicity – including immune effector cell-associated neurotoxicity syndrome – in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity
Zegfrovy received accelerated approval from the US FDA for NSCLC with EGFR Exon 20 Insertion Mutations (Ref)
Dizal announced that the US FDA granted accelerated approved for sunvozertinib (ZEGFROVY; EGFR TKI) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy
The accelerated approval is based on the results from the multinational pivotal Phase 2 WU-KONG1 Part B (WU-KONG1B) trial of sunvozertinib in relapsed or refractory NSCLC with EGFR exon20ins
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
Additionally, Dizal has completed enrollment in its multinational Phase 3 pivotal WU-KONG28 trial of sunvozertinib vs platinum-based doublet chemotherapies in treatment naïve NSCLC patients with EGFR exon20ins across 16 countries and regions
The NICE terminated the appraisal of Adagrasib for KRAS mutant NSCLC (Ref)
The UK's NICE was unable to make a recommendation on BMS' Krazati (adagrasib; small molecule inhibitor of KRAS G12C mutant isoform) for previously treated KRAS G12C mutation-positive advanced NSCLC
After the first committee meeting, the technology appraisal committee's preferred assumptions included using OS data from the Phase 3 KYRSTAL-12 trial in the economic model
However, since this data was immature, BMS will consider restarting this evaluation when the final OS analysis can be included in the economic model
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