FDA Approves Abiraterone/Prednisone for Metastatic Prostate Cancer
The US Food and Drug Administration has approved abiraterone acetate (Zytiga) tablets in combination with prednisone for the treatment of metastatic prostate cancer patients with high-risk, castration-sensitive disease.
FDA Expands Approval of EGFR Inhibitor for Lung Cancer Treatment
The FDA has expanded the approval of afatinib (Gilotrif) to include the first-line treatment of metastatic non–small-cell lung cancer patients whose tumors have non-resistant EGFR mutations, including three newly identified substitution mutations.
FDA Approves First Drug for BRCA-Positive Breast Cancer
The FDA has expanded the approval of the PARP inhibitor olaparib (Lynparza) to include the treatment of patients with metastatic breast cancer who have a mutated BRCA gene.
FDA Approves Brentuximab Vedotin for Cutaneous Lymphoma
The FDA has approved brentuximab vedotin (Adcetris) for the treatment of primary cutaneous anaplastic large-cell lymphoma and CD30-expressing mycosis fungoides in patients who have received prior systemic therapy.
FDA Approves Vemurafenib for Treating Erdheim-Chester Disease
The FDA has expanded the approval of vemurafenib (Zelboraf) to include the treatment of Erdheim–Chester disease in adult BRAF V600–positive patients. This marks the first approval from the agency for treating this rare blood cancer.
FDA Approves Acalabrutinib for Mantle Cell Lymphoma
The FDA has granted accelerated approval to acalabrutinib (Calquence) for the treatment of mantle cell lymphoma in adult patients who have received at least one previous therapy.
FDA Approves CAR T-Cell Therapy for Adults With Aggressive Lymphomas
The FDA has approved the CAR T-cell therapy axicabtagene ciloleucel (Yescarta) for the treatment of large B-cell lymphomas in adults who have failed or relapsed after two or more prior treatments.
FDA Approves Nivolumab for Treating Liver Cancer
The FDA has granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with hepatocellular carcinoma who have previously received sorafenib.
FDA Approves Gemtuzumab Ozogamicin for Acute Myeloid Leukemia
The FDA has approved gemtuzumab ozogamicin (Mylotarg) for the first-line treatment of adults with CD33-positive AML and for pediatric patients with relapsed or refractory CD33-positive AML.
FDA Approves Copanlisib for Relapsed Lymphoma
The FDA has approved the novel PI3K inhibitor copanlisib (Aliqopa) for the treatment of relapsed follicular lymphoma in adult patients who have received at least two prior systemic therapies.
FDA Approves New Acute Lymphoblastic Leukemia Treatment
The FDA has approved inotuzumab ozogamicin (Besponsa) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Cadmium Linked With Increased Endometrial Cancer Rates
Women with increased levels of cadmium, which mimics estrogen in the body, had a higher risk of endometrial cancer, according to a recently published observational study.
FDA Approves Combination for Therapy-Related Acute Myeloid Leukemia
The FDA has approved a fixed combination of daunorubicin and cytarabine (Vyxeos) for the treatment of newly diagnosed therapy-related acute myeloid leukemia (AML) as well as AML with myelodysplasia-related changes.
FDA Approves New Targeted Agent for Acute Myeloid Leukemia
The FDA has approved enasidenib (Idhifa) for the treatment of relapsed or refractory IDH2-mutant acute myeloid leukemia.
FDA Panel Backs Trastuzumab Biosimilar
The FDA Oncologic Drugs Advisory Committee has unanimously voted to recommend approval of the trastuzumab biosimilar MYL-1401O for the treatment of HER2-positive breast cancer.
FDA Approves Ipilimumab for Pediatric Melanoma
The FDA has expanded the approval of ipilimumab (Yervoy) to include the treatment of pediatric melanoma patients 12 years and older with unresectable or metastatic disease.
Blinatumomab Gets Full FDA Approval for B-Cell Precursor ALL
The FDA has expanded the approval of blinatumomab (Blincyto) for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children.
FDA Approves Immunotherapy for MSI-High or MMR-Deficient Tumors
The FDA has granted approval to pembrolizumab for pediatric and adult patients with microsatellite instability (MSI)-high or mismatch repair (MMR)-deficient solid tumors.
Pembrolizumab Gets New Indications in Advanced Cancer
The FDA has granted approval to pembrolizumab (Keytruda) in the first- and second-line settings for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
FDA Approves New First-Line Lung Cancer Treatment
The FDA has approval pembrolizumab (Keytruda), in combination with chemotherapy, for the first-line treatment of patients with metastatic non-squamous non–small-cell lung cancer.
Avelumab Gets FDA Approval for Urothelial Carcinoma
The FDA has granted accelerated approval to avelumab (Bavencio) for treating locally advanced or metastatic urothelial carcinoma patients whose disease progressed following treatment with platinum-containing chemotherapy.
FDA Approves Durvalumab for Advanced Urothelial Carcinoma
The FDA has approved durvalumab (Imfinzi) for the treatment of patients with advanced urothelial carcinoma whose disease has progressed after treatment with platinum-containing chemotherapy.
FDA Approves Regorafenib for Liver Cancer
The FDA has approved regorafenib (Stivarga) for the second-line treatment of hepatocellular carcinoma (HCC) for patients who have previously received sorafenib.
Nivolumab Yields 12-Month Survival of Nearly 60% in Advanced HCC
Interim data from CheckMate 040 showed that nivolumab produces durable responses with promising long-term survival rates in patients with advanced, unresectable hepatocellular carcinoma.
Novel, Immune Therapies Promising in Nonmelanoma Skin Cancers
Treatment of keratinocyte carcinomas such as basal cell carcinoma and cutaneous squamous cell carcinoma with PD-1 checkpoint inhibitors and targeted agents warrant further investigation, according to recently published studies.
FDA Approves Agent for Carcinoid Tumor–Related Diarrhea
The FDA has approved telotristat ethyl (Xermelo) tablets for the treatment of patients with carcinoid syndrome diarrhea that has not responded to somatostatin analogs alone.
FDA Approves Maintenance Lenalidomide for Multiple Myeloma
The FDA has expanded the approval of lenalidomide to include its use as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
Long-Term Data Confirm CRT Benefit in Muscle-Invasive Bladder Cancer
Long-term data from the phase III BC2001 trial confirmed that adding chemotherapy to radiation therapy improves locoregional control and reduces the rate of salvage cystectomy in patients with muscle-invasive bladder cancer.
Tailored Dose-Dense Chemo Fails to Show Benefit in Early Breast Cancer
Tailored dose-dense chemotherapy in high-risk early breast cancer patients did not show a significant improvement in recurrence-free survival compared with standard adjuvant chemotherapy.
Early Trial Finds Immunotherapy Effective in Liver Cancer
Results from a phase I/II study suggest that the immunotherapy nivolumab is safe and effective in advanced hepatocellular carcinoma (HCC).
2 Clarke Drive Cranbury, NJ 08512