Jason M. Broderick

The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended approval of CT-P10, a biosimilar for the monoclonal antibody rituximab (Rituxin), for 3 non-Hodgkin lymphoma indications in a 16-0 vote.

The FDA has approved a once-weekly dosing option of carfilzomib (Kyprolis) to use in combination with dexamethasone for patients with relapsed/refractory multiple myeloma.

The FDA has approved the PD-1 inhibitor cemiplimab (Libtayo) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation.

The FDA has approved the pan-human EGFR tyrosine kinase inhibitor (TKI) dacomitinib (Vizimpro) for treatment of patients with metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations in the frontline setting.

The FDA has approved duvelisib (Copiktra) for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or relapsed/refractory follicular lymphoma.

Combining the PD-L1 inhibitor avelumab (Bavencio) with the VEGF inhibitor axitinib (Inlyta) significantly improved progression-free survival (PFS) compared with sunitinib (Sutent) in treatment-naïve patients with advanced renal cell carcinoma (RCC), according to findings from the phase III JAVELIN Renal 101 study.

The FDA has approved the kinase inhibitor ibrutinib (Imbruvica) for use in combination with rituximab (Rituxan) for the treatment of patients with Waldenström macroglobulinemia, a form of non-Hodgkin lymphoma.

The FDA has granted a full approval to the combination use of pembrolizumab (Keytruda) plus standard chemotherapy in the first-line setting for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC).

The FDA has granted an accelerated approval to nivolumab (Opdivo) for the treatment of patients with small cell lung cancer (SCLC) whose disease has progressed after platinum-based chemotherapy and 1 other line of therapy.

The Food and Drug Administration (FDA) approved a supplemental new drug application for the multikinase inhibitor lenvatinib (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma.

The FDA has approved the monoclonal antibody mogamulizumab-kpkc (Poteligeo) for the treatment of patients with 2 rare subtypes of cutaneous T-cell lymphoma, mycosis fungoides or Sézary syndrome, who have received at least 1 prior systemic therapy.

The FDA has granted breakthrough therapy designation to a triplet combination regimen, which would expedite the development and review of the first treatment for BRAFV600E–mutant metastatic colorectal cancer (mCRC).

The FDA has granted a second breakthrough therapy designation to the combination use of lenvatinib (Lenvima) and pembrolizumab (Keytruda) for the treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient mismatch repair endometrial carcinoma who have progressed after ≥1 prior systemic therapy.

The FDA has approved iobenguane I-131 (Azedra) for adult and pediatric patients 12 years and older with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy.

The FDA has granted a breakthrough therapy designation to atezolizumab (Tecentriq) for use in combination with bevacizumab (Avastin) as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma (HCC).

The FDA has granted a priority review to antibody-drug conjugate sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer following at least 2 prior therapies for metastatic disease.

The US Food and Drug Administration (FDA) approved two ribociclib (Kisqali) combination treatments for subsets of advanced breast cancer in less than a month using a pilot process called the Real-Time Oncology Review.

The frontline combination use of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) yielded a significant reduction in the risk for disease progression or death compared with nab-paclitaxel alone in patients with metastatic or unresectable locally advanced triple-negative breast cancer (TNBC).

The FDA granted an accelerated approval to the immunotherapy combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for use in adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

Adding nelarabine to escalating-dose methotrexate increased the 4-year disease-free survival rate to 91% in pediatric and young adult patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma, according to results from the phase III AALL0434 trial.

Patients with nonmetastatic castration-resistant prostate cancer experienced a 94% reduction in their risk of PSA progression following apalutamide (Erleada) treatment, according to a posthoc analysis from the phase III SPARTAN trial.

The FDA has approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) for the treatment of patients with BRAF-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.

The FDA has granted a priority review to a supplemental new drug application for ibrutinib (Imbruvica) for use in combination with rituximab (Rituxan) as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia, a type of non-Hodgkin lymphoma (NHL).

The FDA has approved bevacizumab (Avastin) for use in combination with carboplatin and paclitaxel, followed by bevacizumab monotherapy, for the treatment of patients with advanced ovarian cancer following initial surgical resection.

Based on results from the phase III MURANO trial, the FDA has granted a regular approval to venetoclax (Venclexta) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, following at least 1 prior therapy.

The FDA has granted a priority review to the PARP inhibitor talazoparib for the treatment of patients with germline BRCA–positive, HER2–negative locally advanced or metastatic breast cancer.

The FDA has granted breakthrough therapy designation to the kinase inhibitor crizotinib (Xalkori) for two indications.

The FDA has granted a priority review to the oral thrombopoietin-receptor agonist eltrombopag (Promacta) in combination with standard immunosuppressive therapy as a frontline treatment for severe aplastic anemia.

The FDA has granted a priority review to the pan-TRK inhibitor larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an NTRK gene fusion.

The FDA has granted a priority review to a new drug application for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia.