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: firstname.lastname@example.org
Ilixadencel Gets Orphan Drug Designation for Soft Tissue SarcomaJanuary 27th 2021
The 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 CanalJanuary 23rd 2021
The 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 CancerJanuary 20th 2021
The 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 CancerJanuary 19th 2021
The 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.
FDA Approves Crizotinib for Pediatric/Young Adult ALK+ Anaplastic Large Cell LymphomaJanuary 15th 2021
The FDA has approved crizotinib (Xalkori) for the treatment of pediatric patients 1 year of age and older and young adults with ALK-positive relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).
Eganelisib/Nivolumab Is Encouraging for Metastatic Urothelial CancerJanuary 13th 2021
The 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, CSCCJanuary 12th 2021
The 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 CancerJanuary 11th 2021
The 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 CancerJanuary 6th 2021
The 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 CancerDecember 19th 2020
The 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 SubsetDecember 18th 2020
The 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 Rituximab Biosimilar for Treatment of NHL, CLL, GPA, and MPADecember 18th 2020
The FDA has approved rituximab-arrx, a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA; Wegener's Granulomatosis), and microscopic polyangiitis (MPA).
FDA Approves Margetuximab-cmkb Plus Chemo in Metastatic HER2+ Breast CancerDecember 17th 2020
The 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 RiskNovember 23rd 2020
Patients 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, GliomaNovember 19th 2020
The 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).
Lung Cancer Lessons from COVID-19November 10th 2020
The oncology community has risen up as a unified front in the battle against coronavirus disease 2019 (COVID-19), launching pivotal research efforts to better understand the enemy and collecting data to develop effective therapeutics to fill the treatment arsenal.
FDA Approves Companion Diagnostic, FoundationOne Liquid CDx, for Olaparib in Prostate CancerNovember 9th 2020
The FDA has approved the FoundationOne Liquid CDx for use as a companion diagnostic with olaparib (Lynparza), which is indicated for select patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer (mCRPC).
Three-Drug Combos May Overcome Targeted Therapy Resistance in MelanomaNovember 2nd 2020
The addition of anti–PD-1/PD-L1 to combination BRAF and MEK inhibition has been shown to improve progression-free survival (PFS) and duration of response (DOR) in patients with BRAF-mutated melanoma, suggesting potential to overcome resistance to targeted approaches, said Grant McArthur, MBBS, PhD, in a presentation during the 2020 SMR Virtual Congress.
Cemiplimab Granted Priority Review for Advanced Lung Cancer With High PD-L1 ExpressionOctober 30th 2020
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.