First-in-Class Therapies:
AstraZeneca’s Capivasertib (Truqap): first AKT inhibitor approved for hormone-receptor-positive, HER2-negative metastatic breast cancer. Its approval alongside a companion diagnostic for PIK3CA, AKT1, or PTEN alterations; precision medicine is highlighted.
J&J’s Talquetamab (Talvey): Distinguished as the first GPRC5D × CD3-targeted T-cell engager, this accelerated approval mAb was granted for heavily pretreated multiple myeloma, highlighting the advancement in immunotherapy approaches.
T-Cell Engaging Bispecific Antibodies:
The approval of bispecific antibodies like Pfizer’s elranatamab, Genmab and AbbVie’s epcoritamab, and Roche/Genentech’s glofitamab, all targeting CD20 × CD3, demonstrates the growing prominence of this modality in oncology, particularly in treating blood cancers.
PD1-Targeted Monoclonal Antibodies (mAbs):
The introduction of Incyte’s retifanlimab and Cohersus’storipalimab expands the PD1/PD-L1 inhibitor class, a cornerstone in modern oncology, particularly for their role in immunotherapy.
ROS1 Inhibitor Class Expansion:
BMS’s repotrectinib represents a new addition to the ROS1 inhibitor class, approved for ROS1-positive non-small-cell lung cancer (NSCLC), and exemplifies the precision targeting of oncogenic drivers.
Other Notable Approvals:
GSK’s momelotinib for myelofibrosis highlights an advancement in treating diseases with a complex pathophysiology, addressing both the primary condition and associated anaemia.
In summary, these developments hold immense potential for improving patient outcomes, although their long-term impact on the overall cancer treatment paradigm remains to be fully realised.
30 years of novel FDA approvals. Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and Research (CDER). See Table 1 for new approvals in 2023. Products approved by the Center for Biologics Evaluation and Research (CBER), including vaccines and gene therapies, are not included in this drug count (Table 2).
Source: Nature Review, January 2nd 2023, 2023 FDA Approvals