The FDA has approved eight oncology indications since Sept. 9. These include label expansions for bladder, colon and breast cancer, and two drugs now approved for previously untreated patients with leukemia and lung cancer.
Here are eight recent oncology drug approvals:
- Anktiva (nogapendekin alfa inbakicept-pmln): The FDA expanded the label for ImmunityBio’s Anktiva, given with Bacillus Calmette-Guérin, Oct. 14 for adults with BCG-unresponsive non-muscle-invasive bladder cancer. Patients with high-grade papillary-only tumors are now eligible. The earlier label was limited to patients with carcinoma in situ.
- Tecentriq (atezolizumab): The FDA approved Genentech’s Tecentriq with fluoropyrimidine and oxaliplatin chemotherapy Oct. 8 for use after surgery in stage 3 mismatch repair-deficient colon cancer. The agency also cleared the subcutaneous version, Tecentriq Hybreza, for the same indication.
- Tukysa (tucatinib): The FDA cleared Pfizer’s Tukysa with trastuzumab and pertuzumab Oct. 7 as maintenance therapy following induction treatment for adults with HER2-positive breast cancer that is metastatic or cannot be surgically removed.
- Jaypirca (pirtobrutinib): Eli Lilly’s Jaypirca moved into the frontline setting Oct. 2. It is now approved for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma who have no known 17p deletion.
- Welireg (belzutifan): The FDA approved Merck’s Welireg with Eisai’s Lenvima (lenvatinib) Sept. 24 for adults with advanced renal cell carcinoma with a clear cell component. The approval covers patients previously treated with a PD-1 or PD-L1 inhibitor.
- Lyrfigtu (lirafugratinib): Elevar Therapeutics’ Lyrfigtu won approval Sept. 23 for adults with previously treated advanced or metastatic cholangiocarcinoma that carries an FGFR2 gene fusion or rearrangement.
- Inluriyo (imlunestrant): The FDA approved Eli Lilly’s Inluriyo with Verzenio (abemaciclib) Sept. 18 for adults with ER-positive, HER2-negative, ESR1-mutated advanced breast cancer that progressed after at least one line of endocrine therapy. Inluriyo was first approved as a single agent in September 2025.
- Hyrnuo (sevabertinib): The FDA expanded the accelerated approval of Bayer’s Hyrnuo Sept. 9 to include adults with advanced nonsquamous non-small cell lung cancer whose tumors have HER2-activating mutations, regardless of whether they have received prior treatment. The drug’s original accelerated approval, in November 2025, was limited to previously treated patients.
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