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
Nivatrotamab Granted Orphan Drug Status for Pediatric Neuroblastoma
October 8th 2020The FDA has granted an orphan drug designation and rare pediatric disease designation to the bispecific antibody nivatrotamab for the treatment of patients with neuroblastoma, according to an announcement from Y-mAbs Therapeutics, Inc.
FDA Gives Refusal to File Letter for Omburtamab to Treat Pediatric Metastatic Neuroblastoma
October 7th 2020Following preliminary review of the data submitted for the agent, the regulatory agency determined that certain portions of the Chemistry, Manufacturing, and Control (CMC) module and the Clinical module of the application require further detail. However, no non-clinical data have been requested.
FDA Approval Sought for TLX591-CDx for Prostate Cancer Imaging
September 28th 2020A new drug application has been submitted to the FDA for TLX591-CDx, a radiopharmaceutical product that targets prostate-specific membrane antigen, for the imaging of prostate cancer through the use of positron emission tomography.
DKN-01 Gets Fast-Track Status for Gastric and GEJ Cancer
September 25th 2020The FDA has granted a fast track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors have high DKK1 expression, who have progressed on or after a fluoropyrimidine- and platinum-containing chemotherapy, and HER2/neu targeted therapy, if appropriate.
FDA Grants Priority Review to Crizotinib for Pediatric ALK-Positive ALCL
September 24th 2020The FDA has granted a priority review to a supplemental new drug application (sNDA) for crizotinib (Xalkori) in the treatment of pediatric patients with ALK-positive relapsed/refractory systemic anaplastic large cell lymphoma (ALCL), according to an announcement from Pfizer, Inc.
EPI-7386 Gets Fast Track Designation for mCRPC Treatment
September 15th 2020The FDA granted a fast track designation to the highly-selective N-terminal domain inhibitor EPI-7386 for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are resistant to standard-of-care options, according to an announcement from ESSA Pharma Inc.
FDA Approves Copper Cu 64 Dotatate Injection for Somatostatin Receptor-Positive NETs
September 10th 2020The FDA has approved copper Cu 64 dotatate injection (Detectnet) for the localization of somatostatin receptor–positive neuroendocrine tumors (NETs), according to an announcement from RadioMedix Inc. and Curium Pharma.
Atezolizumab Plus Paclitaxel in Breast Cancer: FDA Issues Safety, Efficacy Alert
September 8th 2020The FDA has issued an alert to professionals, investigators, and patients that the phase 3 IMpassion131 trial (NCT03125902) failed to show the effectiveness of atezolizumab (Tecentriq) plus paclitaxel in treatment-naïve patients with inoperable locally advanced or metastatic triple-negative breast cancer.
Blinatumomab: New Standard of Care for Pediatric, High-Risk ALL
September 6th 2020Blinatumomab (Blincyto) monotherapy as consolidation therapy prior to allogeneic hematopoietic stem cell transplant (HSCT) resulted a significant improvement in event-free survival (EFS) and a lower risk of recurrence in children with high-risk B-cell precursor (BCP­)–acute lymphoblastic leukemia (ALL).
FDA Approves Oral Azacitidine for AML Treatment
September 1st 2020The FDA has approved CC-486 for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy who are not able to complete intensive curative therapy.
FDA Approves Generic Pemetrexed for Nonsquamous NSCLC
August 26th 2020The FDA has approved a generic form of pemetrexed for intravenous administration as a single-agent in patients with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) that has not progressed following 4 cycles of first-line platinum-based chemotherapy.
FDA Approves Daratumumab Plus Carfilzomib/Dexamethasone for Relapsed/Refractory Myeloma
August 21st 2020The FDA has approved daratumumab in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received 1 or more prior lines of therapy.
Nivolumab Plus Chemotherapy Improves Survival Outcomes in Gastric and Esophageal Cancers
August 13th 2020Nivolumab in combination with chemotherapy as a frontline treatment demonstrated a significant survival benefit in patients with metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.
COVID-19 Mortality: Cancer May Increase Death Risk
July 24th 2020The mortality rate with COVID-19 appears to be higher in patients with cancer—especially those with lung cancer—compared with the general population, according to updated data released from several registries reported during the AACR Virtual Meeting on COVID-19 and Cancer, and several factors associated with mortality are beginning to emerge.
F-627 Shows Strong, Beneficial for Chemotherapy-Induced Neutropenia in Breast Cancer
July 11th 2020Efbemalenograstim alpha (F-627) has demonstrated strong and lasting benefit when used as a treatment for chemotherapy-induced neutropenia in patients with breast cancer, meeting the primary and secondary end points of a phase 3 study.