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Pembrolizumab Receives Approval in Japan for Urothelial Carcinoma
January 9th 2018Pembrolizumab (Keytruda) has been approved in Japan for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy, according to Merck, the manufacturer of the PD-1 inhibitor.
Pembrolizumab/Lenvatinib Combo Granted FDA's Breakthrough Therapy Designation for RCC
January 9th 2018Based on results of the Ib/II Study 111, the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib has been granted a breakthrough therapy designation by the FDA for the treatment of patients with advanced and/or metastatic renal cell carcinoma.
Denosumab Granted FDA Approval for Multiple Myeloma
January 5th 2018Based on data from the phase III 482 study, denosumab (Xgeva) has been granted FDA approval for the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.
Frontline Eltrombopag Receives FDA's Breakthrough Therapy Designation for Severe Aplastic Anemia
January 5th 2018Eltrombopag (Promacta) has been granted a breakthrough therapy designation by the FDA for use in combination with standard immunosuppressive therapy for the first-line treatment of patients with severe aplastic anemia.
The Evolving Role of Targeted Therapies in Melanoma
January 4th 2018Hussein A. Tawbi, MD, discusses the considerations he makes when choosing between immunotherapy and targeted therapy for patients with melanoma and how long-term targeted therapy data can influence treatment decisions.<br />
Expert Discusses Treatment Approaches, Research Needs for Patients With Extracutaneous Melanomas
January 4th 2018Richard D. Carvajal, MD, discusses considerations when diagnosing and treating extracutaneous melanomas and the importance of treating such diseases differently than the more commonly seen melanomas.
A Look Back at FDA News in the Month of December
January 3rd 2018The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.
Ribociclib Granted Breakthrough Therapy Designation by FDA for HR+/HER2- Premenopausal Breast Cancer
January 3rd 2018Based on results of the phase III MONALEESA-7 trial, ribociclib (Kisqali) has been granted a breakthrough therapy designation by the FDA for use in combination with tamoxifen or an aromatase inhibitor as frontline treatment for pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.
Frontline Brentuximab Vedotin Receives FDA's Priority Review for Hodgkin Lymphoma
January 3rd 2018Based on findings from the phase III ECHELON-1 trial, a supplemental biologics application (sBLA) for brentuximab vedotin (Adcetris) in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics.
Novel Iobenguane I-131 Agent Granted FDA's Priority Review for Rare Neuroendocrine Tumors
January 2nd 2018A new drug application for the novel version of the radiopharmaceutical iobenguane I-131 (Azedra) has been granted a priority review by the FDA for the treatment of patients with malignant or recurrent pheochromocytoma or paraganglioma, according to a statement from Progenics Pharmaceuticals, the company developing the novel iodine-131 metaiodobenzylguanidine.
Morse Gives His Perspective on Lines of Therapy for a Patient With Metastatic Colorectal Cancer
December 28th 2017Michael A. Morse, MD, explained his treatment decisions in 1 patient with metastatic colorectal cancer who progresses and requires second-line treatment during a recent <em>Targeted Oncology</em> live case-based peer perspectives dinner.
Ivosidenib Submitted for FDA Approval in IDH1+ AML
December 27th 2017Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton for ivosidenib has been submitted for FDA approval for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia, according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.
Nilotinib Label for CML Updated by FDA With Discontinuation Provision
December 26th 2017The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br />
Stereotactic Radiotherapy Device Given Green Light for Early Breast Cancer by FDA
December 26th 2017Based on findings from a 17-patient study, a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod has been approved by the FDA as a treatment for patients with early breast cancer.<br /> <br />
Clinical Trials Key to Expanding Novel Treatment Options in Metastatic CRC
December 22nd 2017Shubham Pant, MD, discusses therapeutic options for patients with metastatic CRC, while stressing the importance of clinical trials as an avenue to establish more novel treatment decisions in this setting.
Adjuvant Dabrafenib/Trametinib Granted Priority Review by FDA for BRAF+ Melanoma
December 22nd 2017Based on findings of the phase III COMBI-AD study, a supplemental new drug application for dabrafenib (Tafinlar) combined with trametinib (Mekinist) has been granted a priority review by the FDA as an adjuvant treatment for patients with <em>BRAF</em> V600E– or V600K–positive stage III melanoma following complete resection.
Novel Kinase Inhibitor Shows Encouraging Disease Control in Heavily Pretreated GIST
December 22nd 2017A novel kinase switch control inhibitor, DCC-2618, demonstrated an encouraging disease control rate (DCR) of 76% at 12 weeks in heavily pretreated patients with gastrointestinal stromal tumors (GIST) treated with a daily ≥100-mg dose, according to findings of a phase I first-in-human, dose-escalation trial.
Frontline Avelumab/Axitinib Combo Receives FDA's Breakthrough Designation for RCC
December 22nd 2017The PD-L1 inhibitor avelumab (Bavencio) has been granted a breakthrough therapy designation by the FDA for use in combination with the VEGF inhibitor axitinib (Inlyta) in treatment-naïve patients with advanced renal cell carcinoma.
Expert Weighs in On Recent Adjuvant Therapy Data in Melanoma
December 21st 2017For patients with high-risk melanoma, the area of adjuvant treatment has seen little progress until recently. In large part, this is due to the lack of consensus in the community on what treatments to use, when to use them, and in which patients to implement them, explains Michael B. Atkins, MD.