Patritumab

In 2024, the FDA approved 50 new drugs, focusing on cancer, with 15 approvals. Small molecules led with 32 approvals, followed by proteins and oligonucleotides. Notable approvals included a schizophrenia treatment and a NASH drug, marking significant advancements in therapeutic areas.

In 2024, FDA issued CRLs for MDMA in PTSD and several cancer drugs due to manufacturing issues. Biosimilars for aflibercept and denosumab were approved, including first interchangeables. Two drugs for Niemann-Pick disease type C and a novel schizophrenia treatment targeting cholinergic receptors were also approved.

Clinical trials for Sacituzumab govitecan, Trastuzumab emtansine, Trastuzumab deruxtecan, and other treatments show efficacy in various breast cancer types, with significant PFS and OS improvements.

Palbociclib + standard therapy improved progression-free survival in hormone receptor–positive, HER2-positive metastatic breast cancer. No significant overall survival benefit observed among CDK4/6 inhibitor combinations in hormone receptor-positive/HER2-negative breast cancer. Patritumab deruxtecan showed similar efficacy to multiagent chemotherapy in high-risk hormone receptor-positive, HER2-negative breast cancer. Ciltacabtagene autoleucel achieved 100% complete response in high-risk smoldering multiple myeloma. Selinexor + ruxolitinib showed efficacy in myelofibrosis patients previously treated with ruxolitinib.

The IVBM event discussed future oncology, focusing on personalized care, patient education, and collaboration. Experts explored immunotherapy advancements, HER2-targeted therapies, predictive biomarkers, and pharmacy decision-making. Key topics included immunotherapy evolution, lung cancer screening, emerging technologies, antibody-drug conjugates, disparities in molecular testing, and the need for education and collaboration to improve outcomes.

The FDA rejected Johnson & Johnson's subcutaneous amivantamab application due to manufacturing issues, not safety or efficacy. The subcutaneous form was non-inferior to the IV version, offering greater convenience for advanced NSCLC patients with EGFR mutations. J&J is working with the FDA to resolve the issue.

Patritumab deruxtecan with or without Femara showed similar treatment responses to multiagent chemotherapy in high-risk HR-positive, HER2-negative breast cancer, with fewer severe side effects. The phase 2 SOLTI VALENTINE trial reported pCR rates of 4% and ORR of 70% for ADC alone, 2.1% and 81.3% with Femara, and 4.2% and 70.8% for chemotherapy. The ADC also demonstrated antitumor activity and improved tolerability.

Neoadjuvant patritumab deruxtecan (HER3-DXd) with or without letrozole showed comparable pathologic complete response (pCR) and objective response rates (ORR) to multiagent chemotherapy in high-risk, hormone receptor (HR)-positive, HER2-negative breast cancer, with lower grade 3 or higher treatment-related adverse effects. Data from the phase 2 SOLTI VALENTINE trial revealed pCR rates of 4.0% and 2.1% for HER3-DXd alone and with letrozole, respectively, versus 4.2% for chemotherapy, and ORRs of 70.0%, 81.3%, and 70.8%, respectively. The ADC also demonstrated biological antitumor activity and improved tolerability.

Patritumab deruxtecan (HER3-DXd) with or without letrozole showed comparable pathologic complete response (pCR) and objective response rate (ORR) to multiagent chemotherapy with fewer grade 3 or higher treatment-related adverse effects in high-risk, hormone receptor (HR)-positive, HER2-negative breast cancer patients, according to the phase 2 SOLTI VALENTINE trial. The ADC demonstrated antitumor activity and safety, supporting its potential in early breast cancer treatment.

Antibody-drug conjugates (ADCs) enhance breast cancer treatment by targeting tumor cells with cytotoxic drugs, minimizing systemic toxicity. Key ADCs like T-DXd and T-DM1 show promise across HER2+ and HER2- subtypes, despite challenges in sequencing, toxicities, and biomarker identification. Ongoing research aims to refine ADC efficacy and expand their applications in cancer therapy.