Tisotumab vedotin

AstraZeneca and Daiichi Sankyo's Dato-DXd received FDA Breakthrough Therapy designation for EGFRm NSCLC, based on phase II and III study data. They submitted a new BLA for accelerated approval in this indication and withdrew an earlier BLA for nonsquamous NSCLC. Dato-DXd is also under review for HR+ HER2- breast cancer, with regulatory applications ongoing globally.

FDA grants Merck's sacituzumab tirumotecan (sac-TMT) breakthrough therapy designation for advanced non-squamous NSCLC with EGFR mutations, post-chemotherapy progression. This marks the first BTD for sac-TMT, an ADC developed with Kelun-Biotech, with Merck holding global marketing rights except in Greater China.

2024 saw transformative advances in oncology, including improved liquid biopsy assays, AI-driven diagnostics, and expanded use of CDK4/6 inhibitors, antibody-drug conjugates, and immunotherapies. Notable approvals included ribociclib for high-risk breast cancer, T-DXd for HER2-low breast and gastric cancers, and tisotumab vedotin-tftv for cervical cancer. Molecular therapies like lazertinib and amivantamab-vmjw for NSCLC, and selpercatinib for medullary thyroid cancer, also advanced. Lifestyle interventions and metabolic therapies showed potential in improving quality of life and anticancer effects.

Pfizer appoints Chris Boshoff, M.D., PhD, as Chief Scientific Officer and President, Research & Development effective January 1, 2025, succeeding Dr. Mikael Dolsten. Boshoff will oversee all R&D functions and maintain Oncology R&D's integrated structure with Roger Dansey, M.D. as Interim Chief Oncology Officer. Johanna Bendell, M.D. will join Pfizer from Roche in 2025 as Chief Development Officer, Oncology.

Antibody drug conjugates (ADCs) are a transformative class in cancer treatment, with 16 approved products and sales exceeding $10B in 2023. The market is expected to surpass $50B by 2030, driven by over 500 ADCs in clinical trials. Key players include Enhertu, Kadcyla, and Padcev, with significant sales in breast and lung cancers. The US and China lead the market, supported by robust R&D and regulatory environments.

ESMO 2024 Congress featured updates on ovarian, cervical, and endometrial cancers, including niraparib's long-term PFS benefit, gotistobart's potential in platinum-resistant disease, and T-DXd's tumor-agnostic approval. Checkpoint inhibitors are integrating into cervical and endometrial cancer treatments, with clinical trials showing benefits in PFS and OS. ADCs like tisotumab vedotin and TROP2-directed ADCs are emerging as therapeutic options, particularly in endometrial cancer.

The Cancer Antibody Drug Conjugates Market report highlights the transformative potential of ADCs in cancer treatment, with 16 approved products and sales exceeding $10B in 2023. The market is projected to surpass $50B by 2030, driven by ongoing clinical trials and increased R&D efforts. Key players include Padcev, Kadcyla, and Enhertu, with significant development activity in lung and breast cancer. The market is led by the US and China, with major pharmaceutical companies driving innovation.

Pfizer's stock has fallen 60% since its peak during the pandemic, but its Q2 2024 revenue rose 2.1% YoY, with non-COVID revenue up 14%. The company has 113 drugs in its pipeline, including a GLP-1 treatment, and trades at 10.74X forward earnings with a 5.88% dividend yield. Pfizer also has over $10 billion in cash after selling its HLN position, and its stock shows a potential cup and handle formation.