The U.S. Food and Drug Administration (FDA) has approved several significant oncology treatments, expanding therapeutic options for patients battling various types of cancer. These approvals highlight advancements in cancer care and are based on pivotal clinical trial data, offering hope to many.
New Approvals Transform Breast Cancer Treatment
The FDA has granted approval for fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in combination with pertuzumab (Perjeta) as a first-line treatment for patients diagnosed with unresectable or metastatic HER2-positive breast cancer. This landmark decision stems from findings in the phase 3 DESTINY-Breast09 trial (NCT04784715), which revealed a median progression-free survival (PFS) of 40.7 months for the T-DXd and pertuzumab combination compared to 26.9 months for the traditional regimen involving trastuzumab (Herceptin), pertuzumab, and a taxane. The analysis demonstrated a statistically significant hazard ratio of 0.56 (95% CI, 0.44-0.71; P < .0001). Additionally, the objective response rate (ORR) was recorded at 87% for T-DXd plus pertuzumab, compared to 81% in the control group. The FDA also approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro), providing a subcutaneous option for patients with EGFR-mutant non-small cell lung cancer. The approval was supported by data from the phase 3 PALOMA-3 trial (NCT05388669), which indicated noninferior pharmacokinetics for subcutaneous dosing compared to intravenous administration. The ORR was 30% with subcutaneous dosing versus 33% with intravenous, and the median PFS was 6.1 months versus 4.3 months, respectively.
Expanded Access for Prostate and Multiple Myeloma Treatments
In another significant development, the FDA has provided traditional approval for rucaparib (Rubraca) for patients with BRCA mutation-associated metastatic castration-resistant prostate cancer who have previously undergone treatment with an androgen receptor-directed therapy. This decision was informed by results from the phase 3 TRITON3 trial (NCT02975934), which showed a median radiographic PFS of 11.2 months for rucaparib compared to 6.4 months for the physician’s choice of therapy. Furthermore, the median overall survival (OS) was 23.2 months for rucaparib versus 21.2 months for the control group.
The FDA also awarded a Commissioner’s National Priority Voucher to teclistamab-cqyv (Tecvayli) in combination with daratumumab (Darzalex) for patients with relapsed or refractory multiple myeloma. Findings from the phase 3 MajesTEC-3 trial (NCT05083169) indicated that the median PFS was not reached for the teclistamab plus daratumumab group compared to 18.1 months for the control arm. The ORR was significantly higher at 89.0% for the combination therapy versus 75.3% for the control.
Innovative Approaches in Bladder Cancer Treatment
Additionally, research presented in the phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124) revealed that perioperative pembrolizumab (Keytruda) in combination with enfortumab vedotin-ejfv (Padcev) significantly improved event-free survival in cisplatin-eligible patients with muscle-invasive bladder cancer when compared to standard neoadjuvant chemotherapy and surgery. An interim analysis demonstrated positive outcomes regarding overall survival and pathologic complete response, with safety profiles consistent with known toxicities.
These FDA approvals represent a crucial step forward in oncology, providing healthcare professionals and patients with new tools to combat cancer effectively. The ongoing research and clinical trials continue to pave the way for innovative and effective cancer treatments, addressing unmet medical needs in the oncology landscape.
