May 2026 has emerged as one of the most consequential months for oncology drug approvals. The FDA has greenlit four cancer drugs, spanning hematological and solid tumour indications.
On May 1, the FDA approved Veppanu (vepdegestrant) from Arvinas—the first PROTAC therapy to receive regulatory approval. Indicated for ER+/ESR1-mutated advanced breast cancer, it harnesses the cell's natural protein disposal system to degrade disease-driving proteins.
Taiho Oncology secured approval for Inqovi plus venetoclax for newly diagnosed AML in adults 75+ ineligible for intensive chemotherapy. The fully oral regimen achieved 41.6% complete remission in the Phase III ASCERTAIN-V trial.
BeOne Medicines received accelerated approval for Beqalzi (sonrotoclax) in relapsed/refractory mantle cell lymphoma, demonstrating 52% ORR. It introduces new competition in the BCL2 space previously dominated by venetoclax.
On May 8, the FDA approved zenocutuzumab-zbco (Bizengri) for NRG1 fusion-positive cholangiocarcinoma—the first approved treatment for this rare indication, granted under the CNPV pilot program.
The four approvals span diverse modalities—PROTAC degraders, oral combinations, BCL2 inhibitors, and bispecific antibodies—creating varied demand for specialized synthesis, HPAPI handling, and biomanufacturing capacity.
