Darzalex Combined with Revlimid and Dexamethasone New First-Line Regimen for...
On June 27, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with lenalidomide (Revlimid; Celgene) and dexamethasone for the first-line treatment of patients with multiple myeloma...
View ArticleFDA Approves Darzalex Combination for First-Line Treatment of...
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple...
View ArticleNubeqa New Oral Therapy FDA Approved for Nonmetastatic Prostate Cancer
On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer HealthCare), an oral androgen receptor inhibitor, for the treatment of patients with nonmetastatic castration-resistant prostate cancer...
View ArticleRozlytrek Third FDA-Approved Tumor-Agnostic Drug and Second Treatment for...
On August 15, 2019, the FDA accelerated the approval of entrectinib (Rozlytrek; Genentech), an oral kinase inhibitor, for the treatment of adults and adolescents whose cancer involves neurotrophic...
View ArticleTuralio First FDA-Approved Systemic Therapy for Tenosynovial Giant-Cell Tumor
On August 2, 2019, the FDA approved pexidartinib (Turalio; Daiichi Sankyo) capsules, a kinase inhibitor, for adults with symptomatic tenosynovial giant-cell tumor (TGCT), which is associated with...
View ArticleInrebic Receives FDA Approval for Adults with Myelofibrosis
On August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene/Impact Biomedicines), an oral kinase inhibitor, for adults with intermediate-2 or high-risk primary or secondary—post–polycythemia vera...
View ArticleFDA Approved Erleada for Metastatic Castration-Sensitive Prostate Cancer
On September 17, 2019, the FDA approved a new indication for apalutamide (Erleada; Janssen Biotech) for the treatment of patients with metastatic castration-sensitive prostate cancer (CSPC)....
View ArticleKeytruda plus Lenvima Combo FDA Approved for Advanced Endometrial Carcinoma...
On September 17, 2019, the FDA accelerated the approval of a new combination of pembrolizumab (Keytruda; Merck) plus lenvatinib (Lenvima; Eisai) for patients with advanced endometrial carcinoma that is...
View ArticleFDA Approves Daratumumab Combination for First-Line Treatment of...
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone, for first-line treatment of...
View ArticleFDA On In Vitro Diagnostics, Vaping; Cost of Novel Treatments
In This Article FDA Issues Final Guidelines for Use of In Vitro Diagnostics in Oncology Drug Trials Study Finds Patients Bear Higher Costs with Novel Treatment Regimens FDA and CDC Investigate Outbreak...
View ArticleVincristine, Racial Disparities in MM, and HER2 MBC Are in the News
In This Article Critical Shortage of Children’s Cancer Drug Leads to Serious Concerns Study Finds Racial Disparities in Multiple Myeloma Treatment FDA Grants Priority Review to Trastuzumab Deruxtecan...
View ArticleOctober 28, 2019 – Oncology News & Updates
In This Article Zejula Now Approved for Late-Line Ovarian Cancer Trump Set to Nominate Hahn as FDA Commissioner FDA Aims to Improve Breast Implant Guidance Zejula Now Approved for Late-Line Ovarian...
View ArticleNovember 11, 2019 — Oncology News & Updates
In This Article FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia Trump Will Nominate Dr Hahn as Next FDA Commissioner Researchers Report High Rates of E-Cigarette Use...
View ArticleNovember 18, 2019 — Oncology News & Updates
In This Article Teva Will Resume Production of Vincristine in Response to Shortage FDA Fast-Tracks Opdivo plus Yervoy Regimen for Treatment of Advanced Liver Cancer FDA Grants Accelerated Approval to...
View ArticleNovember 25, 2019 – Oncology News & Updates
In This Article Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Despite Some Positive Trends, Report Confirms Lung Cancer...
View ArticleFDA Approves Adakveo to Reduce Vaso-Occlusive Crises in Patients with...
On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell...
View ArticleFDA Grants Priority Review to Keytruda for Patients with High-Risk,...
On December 2, 2019, Merck announced that the FDA has granted priority review for its supplemental biologics license application for the anti–PD-1 agent pembrolizumab (Keytruda). If approved, the drug...
View ArticleRegenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for...
On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial...
View ArticleBrukinsa Receives Accelerated FDA Approval for Mantle-Cell Lymphoma
On November 14, 2019, the FDA granted accelerated approval to zanubrutinib capsules (Brukinsa; BeiGene), a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of adults with mantle-cell...
View ArticleZiextenzo Third Biosimilar to Neulasta Approved for Febrile Neutropenia
On November 5, 2019, the FDA approved pegfilgrastim-bmez (Ziextenzo; Sandoz) as a third biosimilar to Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor. The previous 2 biosimilars to...
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