Drug Approvals

The FDA has accepted a Biologics License Application for ivonescimab (AK112), a new bispecific antibody for patients with EGFR-mutated, nonsquamous non-small cell lung cancer that has progressed after third-generation TKI treatment. Phase 3 HARMONi trial data from 438 patients showed that ivonescimab combined with chemotherapy significantly slowed disease progression. Median progression-free survival improved from 4.4 […]

The FDA has approved ziftomenib (Komzifti) for adults with relapsed or refractory acute myeloid leukemia (AML) harboring NPM1 mutations and lacking other effective treatments. This provides a new option for a challenging AML subgroup. Approval was based on the phase 1/2 KOMET-001 trial, which showed a 21.4% complete remission (CR/CRh) rate, with responses lasting a median of five

The FDA has approved SIR-Spheres Y-90 resin microspheres for treating patients with unresectable hepatocellular carcinoma (HCC) who meet specific clinical criteria, such as no macrovascular invasion, Child-Pugh A cirrhosis, and well-compensated liver function. The approval is supported by the DOORwaY90 study, a multicenter trial evaluating Y-90 as a first-line therapy for unresectable HCC. Results were

The FDA has accepted an application for XS003, a new biosimilar of nilotinib (Tasigna), a standard treatment for chronic myeloid leukemia (CML). Developed by Xspray Pharma using its proprietary HyNap technology, XS003 is designed to improve upon the original drug’s formulation and patient convenience. Clinical data show that XS003 achieves bioequivalence to nilotinib at less

The FDA has approved Libtayo (cemiplimab-rwlc) for adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. Approval was based on the phase 3 C-POST trial of 415 patients, which showed significantly improved disease-free survival with Libtayo versus placebo. Median disease-free survival was not reached in

Keytruda is a type of cancer immunotherapy that helps the body’s immune system fight cancer. It’s used to treat many different cancers, including:Melanoma (a type of skin cancer) • Non-small cell lung cancer • Head and neck cancer • Bladder and urinary tract cancer • Cervical cancer • Certain types of breast cancer • Colorectal cancer • Endometrial cancer • Stomach cancer • Hodgkin

On September 9, 2025, the U.S. Food and Drug Administration approved INLEXZO™ (gemcitabine intravesical system), developed by Janssen Biotech. It is the first device that continuously releases chemotherapy inside the bladder for cancer treatment. Instead of placing liquid chemotherapy in the bladder for one to two hours per visit, this small flexible tube stays in

Innovations in metastatic breast cancer (Stage IV) are transforming care by targeting specific tumor characteristics, extending survival, and improving quality of life. Targeted therapies are at the forefront, with Antibody-Drug Conjugates (ADCs) like Enhertu for HER2-positive/low cancers and Trodelvy for triple-negative disease delivering chemotherapy directly to tumors. CDK4/6 inhibitors combined with hormone therapy slow progression

The FDA has accepted the NDA for gedatolisib under its Real-Time Oncology Review program for HR+/HER2– advanced breast cancer, based on data from the phase 3 VIKTORIA-1 trial in PIK3CA wild-type patients. In the trial, gedatolisib plus fulvestrant and palbociclib reduced progression risk by 76% compared with fulvestrant alone (HR 0.24; P < .0001), achieving

FOTIVDA (tivozanib) is an oral targeted therapy for adults with advanced renal cell carcinoma who have not responded to two or more prior systemic treatments. As a VEGFR tyrosine kinase inhibitor, it blocks VEGFR-1, -2, and -3, disrupting angiogenesis and depriving tumors of the blood supply needed for growth and progression. Treatment is given once