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
Zenocutuzumab Granted Fast Track Designation for Metastatic NRG1+ Solid Tumors
ADC ARX788 Gets Fast Track Status for HER2+ Metastatic Breast Cancer
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.
FDA OKs Berubicin for GBM Treatment
The FDA has approved an investigational new drug application for berubicin for the treatment of patients with glioblastoma multiforme.
Ponatinib Approved by FDA for Resistant or Intolerant Chronic-Phase CML
The FDA has approved ponatinib for the treatment of patients with chronic-phase chronic myeloid leukemia that is resistant or intolerant to at least 2 prior kinase inhibitors.
Adjuvant Osimertinib Approved for EGFR-Positive Lung Cancer
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 Approves Orgovyx for Advanced Prostate Cancer Treatment
The FDA has approved the oral gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix (Orgovyx) as a treatment for patients with advanced prostate cancer.
FDA Gives Priority Review to Frontline Pembrolizumab/Chemo for Esophageal/GEJ Cancer Subset
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 MPA
The FDA has approved rituximab-arrx for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
Devimistat Granted Fast Track Designation for AML Treatment
The FDA has granted a fast track designation to devimistat (CPI-613) for the treatment of patients with acute myeloid leukemia (AML).
FDA Approves Margetuximab-cmkb Plus Chemo in Metastatic HER2+ Breast Cancer
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.
FDA Grants Priority Review to Infigratinib to Treat Cholangiocarcinoma
The FDA has granted a priority review designation to the oral FGFR1-3 selective inhibitor infigratinib for the treatment of patients with cholangiocarcinoma.
Asian Patients With HR+, HER2- Breast Cancer Have Higher Recurrence Risk
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, Glioma
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).
Rilzabrutinib Gets FDA Fast Track Designation for Immune Thrombocytopenia
November 18, 2020 - The FDA has granted a fast track designation to the BTK inhibitor rilzabrutinib for the treatment of patients with immune thrombocytopenia.
AV-GBM-1 Vaccine Improves Glioblastoma Outcomes
AV-GBM-1, a personalized cancer vaccine, demonstrated an improvement in progression-free survival (PFS) in patients with newly diagnosed glioblastoma, according to data from a phase 2 trial (NCT03400917).
Lung Cancer Lessons from COVID-19
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 Cancer
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).
FDA Lifts Hold on CAR T-Cell Trial for Prostate Cancer
The FDA has lifted the clinical hold placed on the phase 1 PSMA-101-001 study (NCT04249947) of the CAR T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.
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.
PVd Confers a Small OS Benefit to Patients With Relapsed/Refractory Multiple Myeloma
Neoadjuvant Durvalumab Combination Misses Mark in EGFR+ NSCLC
Durvalumab Garners Similar OS, Albeit Varied PFS, Outcomes in EGFR+ and EGFR-Wildtype NSCLC Subgroups
Quizartinib Extends Overall Survival Across Multiple Subgroups in FLT3-ITD+ AML
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