Endometrial Cancer Enters Immunotherapy Age
November 9th 2017The tumor-site agnostic FDA approval of the PD-1 inhibitor pembrolizumab (Keytruda) for patients with microsatellite instability-high or mismatch repair deficient solid tumors has helped propel endometrial cancer into the immunotherapy age.
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ctDNA EGFR Testing Identifies Proper Patients for Frontline Osimertinib
October 18th 2017There was a high concordance between central tissue and plasma circulating tumor DNA testing for EGFR mutations in patients enrolled in the phase III FLAURA study of frontline osimertinib (Tagrisso) in NSCLC.
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FDA Grants Priority Review to Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer
October 12th 2017The FDA has granted a priority review to a new drug application for abemaciclib for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
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FDA Approval Sought for Maintenance Rucaparib in Ovarian Cancer
October 10th 2017A supplemental new drug application has been submitted to the FDA for rucaparib as maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
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FDA Grants Pertuzumab Priority Review for HER2+ Early Breast Cancer
September 29th 2017The FDA has granted a priority review to a supplemental biologics license application for pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer.
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FDA Approves Abemaciclib for HR+/HER2- Breast Cancer
September 28th 2017The FDA approved abemaciclib (Verzenio) for use in combination with fulvestrant in women with HR+/HER2- advanced breast cancer with disease progression following endocrine therapy. The CDK4/6 inhibitor has also been approved as a monotherapy for patients with HR+/HER2- breast cancer with metastatic disease who have previously received endocrine therapy and chemotherapy.
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FDA Approves Pembrolizumab for PD-L1+ Gastric Cancer
September 22nd 2017The FDA has approved pembrolizumab for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have received 2 or more lines of chemotherapy, including fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.
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FDA Panel Splits on Adjuvant Sunitinib in High-Risk RCC
September 20th 2017The FDA’s Oncologic Drugs Advisory Committee voted 6-6 on the potential approval of sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are at high risk of recurrence.
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Enzalutamide Succeeds in Phase III Nonmetastatic CRPC Trial
September 14th 2017Adding enzalutamide to androgen deprivation therapy (ADT) significantly improved metastasis-free survival versus ADT alone in patients with nonmetastatic castration-resistant prostate cancer, according to findings from the phase III PROSPER trial.
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FDA Accepts Filing for Binimetinib/Encorafenib Combo in BRAF+ Melanoma
September 14th 2017The FDA has accepted new drug applications supporting use of the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib for BRAF-mutant advanced, unresectable or metastatic melanoma.
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FDA Accepts sNDA for Carfilzomib Label Update in Myeloma
September 1st 2017The FDA has accepted a supplemental new drug application seeking to add overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib for use in patients with relapsed or refractory multiple myeloma.
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FDA Delays Decision on Trastuzumab Biosimilar MYL-1401O
August 30th 2017The FDA has extended its decision deadline by 3 months on a biologics license application for MYL-1401O, a trastuzumab biosimilar co-developed by Mylan and Biocon. A final decision is expected on or before December 3, 2017.
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