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@example.com
Three-Drug Combos May Overcome Targeted Therapy Resistance in Melanoma
The addition of anti–PD-1/PD-L1 to combination BRAF and MEK inhibition has been shown to improve progression-free survival and duration of response in patients with BRAF-mutated melanoma.
Cemiplimab Granted Priority Review for Advanced Lung Cancer With High PD-L1 Expression
The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for cemiplimab-rwlc (Libtayo) for the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with a PD-L1 expression of 50% or greater.
Priority Review Granted to Trastuzumab Deruxtecan for HER2+ Metastatic Gastric Cancer
The FDA has accepted and granted a priority review designation to a supplemental biologics license application for the antibody-drug conjugate (ADC) trastuzumab deruxtecan (Enhertu) for use in patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
RAF Inhibitor Plus Cobicistat Is Promising in BRAF+ Refractory Solid Tumors
PLX8394, a next-generation BRAF inhibitor, in combination with cobicistat (Tybost) was found to demonstrate encouraging clinical activity with an acceptable safety profile in patients with BRAF-mutated, refractory solid tumors, according to results from a phase 1/2 trial (NCT02428712) presented during the 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Therapeutics.
Afatinib Efficacious in EGFR+ NSCLC With Uncommon Mutations, Regardless of Ethnicity
Afatinib (Gilotrif) was found to be effective when used in Asian and non-Asian patients with non–small cell lung cancer (NSCLC) with major uncommon and compound EGFR mutations, irrespective of ethnicity, according to results from a pooled analysis presented during the 2020 IASLC North America Conference on Lung Cancer.
FDA Grants Priority Review to Adjuvant Osimertinib for EGFR-Positive NSCLC
The FDA has granted osimertinib (Tagrisso) a priority review designation to a supplemental new drug application for the adjuvant treatment of patients with early-stage EGFR-mutated non–small cell lung cancer (NSCLC) following complete tumor resection with curative intent.
Nivolumab Plus Cabozantinib Gets Priority Review for Advanced RCC Treatment
The FDA has granted a priority review designation to a supplemental biologics license application and supplemental new drug application for nivolumab (Opdivo) plus cabozantinib (Cabometyx) for the treatment of patients with advanced renal cell carcinoma.
FDA Approval Sought for Pacritinib to Treat Myelofibrosis With Severe Thrombocytopenia
A rolling submission of a new drug application (NDA) for the JAK2/FLT3 inhibitor pacritinib has been initiated for patients with myelofibrosis and severe thrombocytopenia defined as platelet counts of less than 50,000 μL.
Nivatrotamab Granted Orphan Drug Status for Pediatric Neuroblastoma
The 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
Following 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
A 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
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.
FDA Grants Priority Review to Crizotinib for Pediatric ALK-Positive ALCL
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.
Magrolimab Gets FDA Breakthrough Designation Status for MDS Treatment
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.
EPI-7386 Gets Fast Track Designation for mCRPC Treatment
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.
Plinabulin for Chemotherapy-Induced Neutropenia Gets Breakthrough Therapy Designation
The FDA has granted a breakthrough therapy designation to plinabulin for chemotherapy-induced neutropenia (CIN).
FDA Approves Copper Cu 64 Dotatate Injection for Somatostatin Receptor-Positive NETs
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.
Atezolizumab Plus Paclitaxel in Breast Cancer: FDA Issues Safety, Efficacy Alert
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: New Standard of Care for Pediatric, High-Risk ALL
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).
Belumosudil Is Promising for Chronic GVHD
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
Oral Paclitaxel/Encequidar Granted Priority Review for Metastatic Breast Cancer Treatment
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.
FDA Approves Oral Azacitidine for AML Treatment
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.
FDA Approves FoundationOne Liquid CDx Liquid Biopsy for Solid Tumors
The FDA has approved the FoundationOne Liquid CDx, a liquid biopsy for all solid tumors with multiple companion diagnostic indications.
FDA Approves Generic Pemetrexed for Nonsquamous NSCLC
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.
FDA Grants Fast Track Status to Paxalisib for GBM Treatment
The FDA has granted a fast track designation to paxalisib for the treatment of patients with glioblastoma.
FDA Approves Daratumumab Plus Carfilzomib/Dexamethasone for Relapsed/Refractory Myeloma
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.
FDA in Favor of Remestemcel-L for Pediatric GVHD
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 Plus Chemotherapy Improves Survival Outcomes in Gastric and Esophageal Cancers
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.
FDA Approves Guardant360 CDx Liquid Biopsy for Genomic Profiling for Solid Cancers
The FDA has approved Guardant360® CDx for comprehensive genomic profiling in patients with any solid malignant cancer.
SM-88 Granted Orphan Drug Status for Pancreatic 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.
Olanzapine Significantly Reduces CINV in Patients Receiving MEC
Reimagining Frailty Screenings in Head and Neck Cancer
Screening for Pain and Depression is Not Enough in Cancer Care
Niraparib-Based Triplet Therapy Offers OS Advantage in BRCA1/2+ mCRPC
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