Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
FDA Grants Sintilimab/Pemetrexed Review for Frontline Nonsquamous NSCLC
May 19th 2021A biologics license application for sintilimab injection plus pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with nonsquamous non–small cell lung cancer has been accepted for FDA review.
FDA Approves Pegcetacoplan for Paroxysmal Nocturnal Hemoglobinuria
May 17th 2021The FDA has approved pegcetacoplan (Empaveli) for the treatment of adults with paroxysmal nocturnal hemoglobinuria who are treatment naïve and those who are switching from the C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris).
AI-Based Focal Therapy System Get a Breakthrough Device Designation for Prostate Cancer Treatment
May 12th 2021The FDA has granted a breakthrough device designation to the Avenda Health Focal Therapy System, a male “lumpectomy” product under development to treat patients with prostate cancer in office while preserving quality of life.
Drug Combo Improves PFS in mCRPC
May 3rd 2021The novel oral TKI masitinib in combination with docetaxel and prednisone resulted in improved progression-free survival compared with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer, meeting the predefined primary end point of the phase 2b/3 AB12003 trial.
Adjuvant Nivolumab Granted Priority Review for Muscle-Invasive Urothelial Carcinoma
May 2nd 2021The FDA has granted a priority review designation to a supplemental biologics license application for nivolumab for use as an adjuvant treatment in patients with surgically resected, high-risk, muscle-invasive urothelial carcinoma.
FDA Authorizes Marketing for AI Colon Cancer Detection Device
April 12th 2021The FDA has authorized the marketing of the first device that utilizes artificial intelligence based on machine learning to help clinicians detect lesions like polyps or suspected tumors in the colon in real time during a colonoscopy.
FDA Approves Additional Cetuximab Dose for KRAS Wild-Type, EGFR-Expressing CRC, Head and Neck Cancer
April 7th 2021The FDA has approved a new biweekly dosing regimen of 500 mg/m2 as a 120-minute intravenous infusion for cetuximab (Erbitux) for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.
Futibatinib Granted Breakthrough Therapy Designation for FGFR2+ Advanced Cholangiocarcinoma
April 2nd 2021The FDA has granted a breakthrough therapy designation to the FGFR inhibitor futibatinib for the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma that harbors FGFR2 gene rearrangements, including fusions.
FDA Approves Isatuximab Plus Carfilzomib/Dexamethasone for Relapsed/Refractory Myeloma
March 31st 2021The FDA has approved isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received 1 to 3 lines of therapy.
FDA Defers Decision on Pembrolizumab for TNBC: Here's Why
March 30th 2021Ahead of the Prescription Drug User Fee Act action date for the application, the regulatory agency’s Oncologic Drugs Advisory Committee voted 10 to 0 that a decision be deferred until further findings from KEYNOTE-522 trial become available.
Palbociclib/Letrozole Improves Survival in HR+ Metastatic Breast Cancer
March 26th 2021Palbociclib in combination with endocrine therapy resulted in improved survival outcomes in a real-world population of patients with hormone receptor–positive, HER2-negative, metastatic breast cancer vs letrozole alone in the first-line setting.
FDA Approves Pembrolizumab for Advanced Esophageal/GEJ Cancer
March 22nd 2021The FDA has approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation.
Belzutifan Granted Priority Review for VHL Disease–Associated RCC
March 17th 2021The FDA has granted priority review to the new drug application for the HIF-2α inhibitor belzutifan for the potential treatment of patients with von Hippel-Lindau–associated renal cell carcinoma that does not require immediate surgery.
Study Explores Actionable Pathologic Variants in Caribbean Women With Breast or Ovarian Cancer
March 11th 2021One in 7 Caribbean-born individuals with either breast or ovarian cancer had hereditary disease with an actionable pathogenic variant, which provides the opportunity for the utilization of targeted therapeutics and precise prevention strategies.
Tipifarnib Gets Breakthrough Therapy Designation for HRAS-Mutated HNSCC
February 25th 2021The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma with variant allele frequency of 20% or higher following progressive disease on platinum-based chemotherapy.