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
Vicineum Granted Priority Review for High-Risk, BCG-Unresponsive Bladder Cancer
February 18th 2021The FDA has accepted and granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.
Sotorasib Granted Priority Review for KRAS G12C–Mutated Advanced or Metastatic NSCLC
February 17th 2021The FDA has granted priority review to sotorasib for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, after at least 1 previous systemic therapy.
FDA Approves Trilaciclib for Chemo-Induced Bone Marrow Suppression in Small Cell Lung Cancer
February 12th 2021The FDA has approved trilaciclib to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.
Cancer Drugs Spark Hope in Combatting COVID-19
February 5th 2021In response to the novel coronavirus disease 2019 (COVID-19) pandemic, investigators around the world channeled their efforts into acquiring a better understanding of the virus so that they could rapidly identify any weapons that may be used in the fight against its spread; this included turning to tried-and-true cancer drugs to see whether they could be repurposed to address this pressing need.
mRNA Vaccines: From Cancer to COVID-19
February 4th 2021Recent progress made with messenger RNA (mRNA) vaccines has led to amplified protein translation, stronger modulation of immunogenicity, and improved delivery, which has all contributed to an evolution in the application of these products in the field of cancer.
Ilixadencel Gets Orphan Drug Designation for Soft Tissue Sarcoma
January 27th 2021The FDA has granted the cell-based, off-the-shelf immune primer ilixadencel an orphan drug designation for use as a treatment option in patients with soft tissue sarcoma (STS), according to an announcement from Immunicum AB.
Retifanlimab Granted Priority Review for Squamous Cell Carcinoma of the Anal Canal
January 23rd 2021The FDA has granted priority review to a biologics license application (BLA) for retifanlimab (INCMGA 0012) for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who were intolerant of or who had progressed on platinum-based chemotherapy.
Nivolumab/Chemo Granted Priority Review for Frontline Metastatic Gastric, GEJ, and Esophageal Cancer
January 20th 2021The FDA has granted a priority review to a supplemental biologics license application for nivolumab (Opdivo) in combination with a fluoropyrimidine- and platinum-containing chemotherapy for use in patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma.
Padeliporfin ImPACT Granted Fast Track Status for Upper-Tract Urothelial Cancer
January 19th 2021The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer (UTUC), according to an announcement from Steba Biotech.
Eganelisib/Nivolumab Is Encouraging for Metastatic Urothelial Cancer
January 13th 2021The addition of eganelisib (IPI-549) to nivolumab (Opdivo) was found to elicit encouraging responses and improve progression-free survival (PFS) compared with single-agent nivolumab in patients with platinum-refractory, immunotherapy-naïve, advanced, metastatic urothelial cancer, according to an update from the phase 2 MARIO-275 (NCT03980041).
Cavrotolimod Granted Fast Track Status for Merkel Cell Carcinoma, CSCC
January 12th 2021The FDA has granted fast track designations to cavrotolimod (AST-008) for use in combination with a PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma (MCC) that is refractory to previous PD-1 blockade and for use in combination with a PD-1/PD-L1 agent in those with advanced or metastatic cutaneous squamous cell carcinoma (CSCC) that is refractory to previous PD-1/PD-L1 blockade.
FDA Updates Darolutamide Label for Prostate Cancer
January 11th 2021The FDA has approved a supplemental new drug application to add overall survival (OS) and other secondary end point data from the phase 3 ARAMIS trial (NCT02200614) to the prescribing information for darolutamide (Nubeqa) for the treatment of patients with nonmetastatic prostate cancer (nmCRPC).
ADC ARX788 Gets Fast Track Status for HER2+ Metastatic Breast Cancer
January 6th 2021The FDA has granted a fast track designation to the investigational antibody-drug conjugate (ADC) ARX788 for use as a monotherapy in the treatment of patients with advanced or metastatic HER2-positive breast cancer who have previously received 1 or more HER2-targeted regimens in the metastatic setting.
Adjuvant Osimertinib Approved for EGFR-Positive Lung Cancer
December 19th 2020The FDA has approved osimertinib (Tagrisso) for use as an adjuvant treatment following tumor resection in patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
FDA Gives Priority Review to Frontline Pembrolizumab/Chemo for Esophageal/GEJ Cancer Subset
December 18th 2020The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab in combination with platinum- and fluoropyrimidine-based chemotherapy as a first-line treatment in patients with locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer.
FDA Approves Margetuximab-cmkb Plus Chemo in Metastatic HER2+ Breast Cancer
December 17th 2020The FDA has approved margetuximab-cmkb (Margenza) plus chemotherapy for use in adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which was for metastatic disease.
Asian Patients With HR+, HER2- Breast Cancer Have Higher Recurrence Risk
November 23rd 2020Patients from Asian countries with hormone receptor (HR)–positive, HER2-negative breast cancer may have a higher risk of disease recurrence than those from non-Asian countries, suggesting that this population may benefit from additional adjuvant treatment with abemaciclib (Verzenio).
PTC596 Granted Fast-Track Designations for Leiomyosarcoma, Glioma
November 19th 2020The FDA has granted a fast track designation and an orphan drug designation to the orally bioavailable small molecule tubulin-binding agent PTC596 for potential use in patients with leiomyosarcoma; the agent also received a rare pediatric disease designation and an orphan drug designation for potential use in patients with diffuse intrinsic pontine glioma (DIPG).