By Karen Blum
GRAPEVINE, Texas—After a slow year for FDA approvals of new oncolytic agents in 2022, the pipeline is robust, with an estimated 4,800 agents in various stages of development and the number of new agents expected to be approved in 2023 anticipated to hit double digits, a presenter said at the NASP 2023 Annual Meeting & Expo.
Notable approvals for 2022 included mirvetuximab-soravtansine-gynx (Elahere, ImmunoGen) for fallopian tube peritoneal cancer, mosunetuzumab-axgb (Lunsumio, Genentech) for follicular lymphoma, and teclistimab-cqyv (Tecvayli, Janssen) for relapsed multiple myeloma, said Ray Tancredi, RPh, MBA, CSP, the divisional vice president for specialty pharmacy development brand pharmacy and vaccine purchasing at Walgreens. Looking at sales, he said, lenalidomide (Revlimid, Celgene) led in oral cancer drugs, reaching about $8 billion in 2022.
Seven approvals have occurred so far in 2023, including glofitamab-gxbm (Columvi, Genentech) for large B-cell lymphoma and most recently, momelotinib (Ojjara, GSK) for myelofibrosis with anemia, Mr. Tancredi said.
Several agents in the near-term pipeline for approval target non-small cell lung cancers (NSCLCs), he continued, which remain the leading cause of cancer deaths for both men and women in the United States. Some 85% of lung cancers are classified as NSCLC, he said, and more than 1 million people worldwide per year are diagnosed with the disease. Agents to watch include the following:
• Telisotuzumab vedotin (AbbVie) is an investigational antibody?drug conjugate injection granted breakthrough designation, that could launch by the end of 2024.
• Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca) is an engineered anti-tumor?associated calcium signal transducer (TROP) 2 monoclonal antibody?topoisomerase I inhibitor conjugate. This drug is also an injection that could launch by the end of next year. Phase 3 trial results have demonstrated statistically significant improvement in progression-free survival versus standard of care, Mr. Tancredi noted.
• Savolitinib (Orpathys, AstraZeneca, HUTCHMED) is an oral mesenchymal epithelial transition (c-Met) kinase inhibitor that could launch by the end of this year. It’s also under development for other tumor types, including kidney and gastric cancers, as a single treatment or in combination with other medications.
• Domvanalimab (Gilead/Arcus Biosciences) is an injection that is an anti?T-cell immunoreceptor with Ig and ITIM domain (TIGIT) monoclonal antibody. It’s being evaluated in four phase 3 trials across lung and gastrointestinal cancers and could launch by the end of 2024.
• Repotrectinib (BMS) is an oral anaplastic lymphoma kinase (ALK), ROS1 kinase and tyrosine kinase A/B/C inhibitor that could launch by the end of this year. It has been granted an orphan drug designation by the FDA and has demonstrated “clinically meaningful results,” Mr. Tancredi said. The drug also has been granted three breakthrough therapy designations by the FDA for several metastatic lung cancer conditions.
• Olafertinib (Checkpoint Therapeutics) is a third-generation irreversible kinase inhibitor that works against selective mutations of epidermal growth factor receptor seen in about 20% of patients with advanced NSCLC, Mr. Tancredi said. This medication, an oral product, could launch by this year’s end. It’s been shown to be potentially effective as monotherapy or in combination with other anti-tumor immune response?potentiating compounds, he said.
Mr. Tancredi covered pipeline agents for other malignancies, such as gastrointestinal, skin, breast, bone, blood and brain cancers, as well as oncology gene and cell therapy products in development for non-Hodgkin lymphoma, bone cancer, melanoma and other types of cancer.
Mr. Tancredi reported no relevant financial disclosures beyond his stated employment.