The FDA has granted a breakthrough therapy designation to the combination of the BRAF inhibitor Braftovi (encorafenib), the MEK inhibitor Mektovi (binimetinib), and the EGFR inhibitor Erbitux (cetuximab) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC) following one or two prior lines of treatment in the metastatic setting.
The FDA has granted a breakthrough therapy designation to the combination of Lenvima (lenvatinib) and Keytruda (pembrolizumab) 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 at least one prior systemic therapy.
The Food and Drug Administration (FDA) has approved Azedra (iobenguane I-131) for adult and pediatric patients aged 12 years or older with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy.
The FDA has approved the combination of the BRAF inhibitor Braftovi (encorafenib) and the MEK inhibitor Mektovi (binimetinib) for the treatment of patients with BRAF-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.
The FDA has accepted a supplemental biologics license application (sBLA) for the use of Keytruda (pembrolizumab) as an adjuvant treatment for patients with resected, high-risk stage 3 melanoma, according to Merck (MSD), the manufacturer of the PD-1 inhibitor.
The FDA has granted a priority review to a supplemental new drug application (sNDA) Imbruvica (ibrutinib) for use in combination with Rituxan (rituximab) as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.
If approved, it will become the second PARP inhibitor in the breast cancer space.
The Food and Drug Administration (FDA) has granted a priority review to a new drug application (NDA) for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML), according to Astellas Pharma, the manufacturer of the FLT3 inhibitor.
The FDA has granted a priority review to a new drug application (NDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an NTRK gene fusion, according to Bayer and Loxo Oncology, the codevelopers of the pan-TRK inhibitor.
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for Tecentriq (atezolizumab) to be used in combination with Avastin (bevacizumab), carboplatin and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC).
The combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib) was granted Food and Drug Administration (FDA) approval for the treatment of patients with BRAF V600E– or V600K–positive stage 3 melanoma following complete resection.
The Food and Drug Administration (FDA) granted a priority review to a biologics license application (BLA) for an immunotherapy agent – cemiplimab – to be used to treat metastatic cutaneous squamous cell carcinoma (a type of skin cancer; CSCC) or patients with locally advanced CSCC who are not eligible for surgery.
The Food and Drug Administration (FDA) granted a priority review to a supplemental biologics license application (sBLA) for frontline Keytruda (pembrolizumab) for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), according to Merck (MSD), the manufacturer of the PD-1 inhibitor.
The Food and Drug Administration (FDA) granted priority review to a supplemental biologics license application for Opdivo (nivolumab) for the treatment of patients with small cell lung cancer with disease progression following two or more lines of therapy.
The Food and Drug Administration (FDA) granted duvelisib a priority review to a new drug application (NDA) for full approval to treat patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic leukemia (CLL/SLL). The FDA also granted an accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma.
Tasigna (nilotinib) was granted Food and Drug Administration (FDA) approval, to be used in the first- and second-line setting for pediatric patients 1 year old or older who have Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Adcetris (brentuximab vedotin), in combination with chemotherapy, was granted approval by the Food and Drug Administration (FDA) as a frontline treatment option for patients with stage 3 or 4 classical Hodgkin lymphoma, according to the manufacturer of the drug, Seattle Genetics.
The Food and Drug Administration (FDA) has approved Verzenio (abemaciclib) for use in combination with a hormonal therapy for initial treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.
FDA approves first treatment approved for stage 3 unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation.
The Food and Drug Administration (FDA) approved Erleada (apalutamide) for the treatment of patients who have nonmetastatic castration-resistant prostate cancer (CRPC). The drug is now the first FDA-approved treatment in this setting.
Lutathera (lutetium [177Lu] oxodotreotide) was approved for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) – a rare cancer that affects the pancreas and gastrointestinal tract.
The Food and Drug Administration (FDA) approved a supplemental new drug application that adds overall survival (OS) data from the phase 3 ENDEAVOR trial to the label for Kyprolis (carfilzomib) to treat patients with relapsed or refractory multiple myeloma.
The Food and Drug Administration granted a priority review to a supplemental biologics license application for Kymriah (tisagenlecleucel) to be used to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma who either relapse or are not eligible for an autologous stem cell transplant.
Lynparza (olaparib) was granted approval by the Food and Drug Administration (FDA) for the treatment of patients with BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy. Also, patients who have HR-positive disease should have prior endocrine therapy or they would not be considered appropriate for such treatment.
A new combination – Keytruda (pembrolizumab) plus Lenvima (lenvatinib) – was granted a breakthrough therapy designation to treat patients with advanced and/or metastatic renal cell carcinoma (RCC).
Xgeva (denosumab) was granted approval by the Food and Drug Administration (FDA) to prevent skeletal-related events (SREs) in patients with multiple myeloma, according to Amgen, the developer of the drug.
Kisqali (ribociclib) was granted a breakthrough therapy designation by the Food and Drug Administration (FDA) to be used in combination with tamoxifen or an aromatase inhibitor (AI) in the frontline treatment of pre- or perimenopausal women who have hormone receptor-positive HER2-negative advanced or metastatic breast cancer.
Adcetris (brentuximab vedotin) was granted a priority review to a supplemental biologics license application (sBLA) by the Food and Drug Administration (FDA) to be used in combination with Adriamycin, vinblastine and dacarbazine (AVD) to treat patients with classical Hodgkin lymphoma in the frontline setting, according to Seattle Genetics, the company developing the drug.
The Food and Drug Administration (FDA) has granted a priority review to a supplemental new drug application (sNDA) for the use of Tafinlar (dabrafenib) combined with Mekinist (trametinib) as an adjuvant treatment for patients with BRAFV600E– or V600K–positive stage 3 melanoma following complete resection.
The FDA has granted a priority review to a new drug application (NDA) for apalutamide (ARN-509) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.
