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: [email protected]
The 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.
The 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.
The FDA has granted a breakthrough therapy designation to magrolimab for the treatment of patients with newly diagnosed myelodysplastic syndrome (MDS), according to an announcement from Gilead Sciences, Inc.
The 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.
The FDA has granted a breakthrough therapy designation to plinabulin for chemotherapy-induced neutropenia (CIN).
The 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.
The 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 (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).
The orally available belumosudil continues be promising in patients with chronic graft-versus-host disease (cGVHD) who have received 2 or more prior lines of systemic therapy
The FDA has granted a priority review to a new drug application for oral paclitaxel and encequidar for use in patients with metastatic breast cancer.
The 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.
The FDA has approved the FoundationOne Liquid CDx, a liquid biopsy for all solid tumors with multiple companion diagnostic indications.
The 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.
The FDA has granted a fast track designation to paxalisib for the treatment of patients with glioblastoma.
The 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.
The FDA’s Oncologic Drugs Advisory Committee voted in favor of approving remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease.
Nivolumab 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.
The FDA has approved Guardant360® CDx for comprehensive genomic profiling in patients with any solid malignant cancer.
The FDA granted an orphan drug designation to the oral investigational modified proprietary tyrosine derivative SM-88 as a treatment for patients with pancreatic cancer.
The 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.
To date, no FDA-approved options are available for patients under the age of 12 with SR-aGVHD in the United States, underscoring a great unmet need.
The FDA has granted a fast track designation for the PKCβ inhibitor enzastaurin for the treatment of patients with newly diagnosed glioblastoma.
The situation with the coronavirus-19 pandemic continues to rapidly evolve, but one thing is clear: this is much more than just the common cold.
The FDA has accepted a supplemental new drug application (sNDA) seeking approval for selinexor (Xpovio) for the treatment of patients with multiple myeloma following at least 1 previous line of therapy.
Efbemalenograstim 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.
The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab monotherapy as a treatment for adult patients with relapsed/refractory classical Hodgkin lymphoma.
Dexamethasone, a corticosteroid traditionally used in cancer treatment, may be beneficial in treating patients with the novel coronavirus 2019 (COVID-19).
The FDA has issued a clinical hold on the phase 1 MELANI-01 trial evaluating the CAR T-cell product UCARTCS1A in the treatment of patient with relapsed/refractory multiple myeloma, according to Cellectis, the manufacturer of the product.
A new drug application (NDA) has been submitted to the FDA for pralsetinib (BLU-667) for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion–positive thyroid cancers, according to an announcement from Blueprint Medicines, the developer of the drug.
