FDA Panel Unanimously Supports Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma
July 15th 2020The Food and Drug Administration’s Oncologic Drugs Advisory Committee voted in favor of the agency approving belantamab mafodotin to treat patients with relapsed or refractory multiple myeloma who have previously received at least four therapies.
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Erleada May Extend Subsequent Progression in Men With Castration-Resistant Prostate Cancer
September 28th 2019Morever, the next-generation androgen receptor improved overall survival, compared with placebo, in patients with nonmetastatic castration-resistant prostate cancer, according to updated findings of the phase 3 SPARTAN trial.
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FDA Approves Xpovio to Treat Relapsed/Refractory Multiple Myeloma
July 3rd 2019The Food and Drug Administration has granted an accelerated approval to Xpovio in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received more than four prior therapies.
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FDA Approves Frontline Darzalex/Rd in Transplant-Ineligible Myeloma
June 28th 2019The FDA has approved the combination of Darzalex with Revlimid and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.
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FDA Grants Priority Review to Zejula for Late-Stage Ovarian Cancer
June 25th 2019The FDA has granted a priority review designation to a supplemental biologics license application for Zejula for the treatment of certain patients with advanced ovarian, fallopian tube or primary peritoneal cancer.
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FDA Approves First Malignant Pleural Mesothelioma Therapy in Over 15 Years
May 24th 2019The Food and Drug Administration has approved the NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy for the front-line treatment of patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma.
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Food and Drug Administration Panel Supports Pexidartinib for Tenosynovial Giant Cell Tumor
May 14th 2019The FDA’s Oncologic Drugs Advisory Committee voted in favor of the agency approving pexidartinib to treat adult patients with symptomatic tenosynovial giant cell tumor – a rare, benign lesion that can be locally aggressive and often recurring.
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FDA Approves Tibsovo for Frontline IDH1-Mutant Acute Myeloid Leukemia
May 2nd 2019The FDA has approved a supplemental new drug application for Tibsovo as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia who are 75 years and older or are ineligible to receive intensive chemotherapy.
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FDA Approves Tecentriq Plus Chemo for Small Cell Lung Cancer
March 19th 2019The Food and Drug Administration (FDA) has granted an approval to the combination of Tecentriq (atezolizumab) with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
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The FDA Approves Fourth Herceptin Biosimilar
March 12th 2019The Food and Drug Administration (FDA) has granted an approval to Trazimera (PF-05280014; trastuzumab-qyyp), a Herceptin (trastuzumab) biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
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FDA Approves Cinvanti Injection for Chemotherapy-Induced Nausea and Vomiting
March 2nd 2019The U.S. Food and Drug Administration has expanded the approval of Cinvanti injectable emulsion to include a two-minute intravenous use for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.
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Erleada Improves Survival in Prostate Cancer Subset
February 1st 2019In topline findings from the phase 3 TITAN trial (NCT02489318) announced today by Janssen, Erleada (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) versus placebo in patients with metastatic castration-sensitive prostate cancer.
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FDA Expands Alimta Approval for Use With Immunotherapy and Chemo in Lung Cancer
January 31st 2019The FDA has expanded the indication for Alimta (pemetrexed) injection in combination with Keytruda (pembrolizumab) and platinum-based chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) without EGFR or ALK alterations.
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FDA Approves Third Herceptin Biosimilar
January 19th 2019The FDA has granted an approval to Ontruzant (SB3; trastuzumab -dttb), a Herceptin (trastuzumab) biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.
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Zanubrutinib Granted Breakthrough Designation for Mantle Cell Lymphoma
January 15th 2019The Food and Drug Administration (FDA) has granted the investigational BTK inhibitor zanubrutinib (BGB-3111) a breakthrough therapy designation for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least one prior therapy, according to BeiGene, the company manufacturing the agent.
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FDA Approves Frontline Tecentriq Regimen for NSCLC
December 7th 2018The Food and Drug Administration has approved Tecentriq (atezolizumab) for use in combination with Avastin (bevacizumab), carboplatin, paclitaxel, the treatment combination known as ABCP, for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).
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LOXO-292 Granted Breakthrough Designation for Thyroid Cancer
October 15th 2018The Food and Drug Administration has granted LOXO-292 a breakthrough therapy designation for the treatment of patients with advanced RET fusion–positive thyroid cancer who require systemic therapy, have progressed on prior treatment, and have no other acceptable alternative treatment options, according to a statement from Loxo Oncology, the developer of the selective RET inhibitor.
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Will Immunotherapy and Radiation Be Combined in Lung Cancer Treatment?
December 27th 2017Checkpoint inhibitors continue to show promise in the treatment of patients with non-small cell lung cancer (NSCLC), but researchers are now exploring the efficacy of these agents when combined with radiation therapy (RT).
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