The U.S. Food and Drug Administration (FDA) has recently approved several significant treatments in oncology, enhancing options for patients battling various forms of cancer. These approvals reflect ongoing advancements in cancer care, backed by critical clinical trial data.
New Approvals for Breast Cancer and Lung Cancer
One of the standout decisions involves the approval of fam-trastuzumab deruxtecan-nxki (T-DXd; marketed as Enhertu) in combination with pertuzumab (Perjeta) as a first-line treatment for patients with unresectable or metastatic HER2-positive breast cancer. This decision was influenced by results from the phase 3 DESTINY-Breast09 trial (NCT04784715), which revealed a median progression-free survival (PFS) of 40.7 months with the T-DXd and pertuzumab combination compared to 26.9 months for the traditional treatment of trastuzumab, pertuzumab, and a taxane. The confirmed objective response rate (ORR) was 87% for the new combination versus 81% in the control arm.
In a separate approval, the FDA cleared amivantamab and hyaluronidase-lpuj (Rybrevant Faspro), a subcutaneous formulation for patients with EGFR-mutant non-small cell lung cancer. This decision was supported by findings from the phase 3 PALOMA-3 trial (NCT05388669), which indicated noninferior pharmacokinetics for the subcutaneous version compared to its intravenous counterpart. The subcutaneous formulation demonstrated an ORR of 30% versus 33% for intravenous dosing, with a median PFS of 6.1 months compared to 4.3 months for intravenous administration.
Advancements in Prostate and Multiple Myeloma Treatments
In another development, the FDA granted traditional approval to rucaparib (Rubraca) for patients with BRCA mutation-associated metastatic castration-resistant prostate cancer who have previously undergone treatment with an androgen receptor-directed therapy. Findings from the phase 3 TRITON3 trial (NCT02975934) showed that rucaparib improved median radiographic PFS to 11.2 months, significantly better than the 6.4 months recorded for the control group. The median overall survival (OS) was also promising at 23.2 months for those on rucaparib versus 21.2 months for the control.
The FDA also issued a Commissioner’s National Priority Voucher to teclistamab-cqyv (Tecvayli) in combination with daratumumab (Darzalex) for patients with relapsed or refractory multiple myeloma. This decision followed results from the phase 3 MajesTEC-3 trial (NCT05083169), where the median PFS was significantly greater for the combination therapy, with an ORR of 89% compared to 75.3% in the control arm.
Promising Outcomes in Bladder Cancer
In the realm of muscle-invasive bladder cancer, the combination of pembrolizumab (Keytruda) and enfortumab vedotin-ejfv (Padcev) demonstrated significant improvements in event-free survival compared to traditional neoadjuvant chemotherapy and surgery. These findings emerged from the phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124), where interim analyses revealed that the combination not only met key secondary endpoints of overall survival but also pathologic complete response rates, confirming the safety profile of both agents without new safety signals.
These recent FDA approvals underscore a pivotal moment in oncology, presenting new hope for patients facing aggressive cancers. Ongoing research and development in this field continue to drive innovations that aim to improve patient outcomes significantly.
