Kristi Rosa

Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

Articles

FDA Approval Sought for Amivantamab Plus Chemo in EGFR Exon 20 Insertion+ NSCLC

August 25th 2023

A supplemental biologics license application seeking the expanded approval of amivantamab-vmjw in combination with carboplatin plus pemetrexed for use in the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations has been submitted to the FDA.

Sovleplenib Elicits Durable Responses in Primary Immune Thrombocytopenia

August 24th 2023

Sovleplenib provided a statistically significant and clinically meaningful increase in durable response rate over placebo in adult patients with primary immune thrombocytopenia in China.

REGAL Trial Examining Galinpepimut-S in AML to Continue Without Modifications

August 24th 2023

An independent data monitoring committee has recommended that the phase 3 REGAL trial evaluating galinpepimut-S in patients with acute myeloid leukemia should continue without modifications.

Sunvozertinib Approved in China for NSCLC With EGFR Exon 20 Insertion Mutations

August 23rd 2023

The National Medical Products Administration of China has approved sunvozertinib for use in adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy.

FDA Awards Orphan Drug Designation to NXC-201 for Multiple Myeloma

August 23rd 2023

The FDA has granted orphan drug designation to NXC-201 for use as a potential therapeutic option in patients with multiple myeloma.

Trastuzumab Deruxtecan Approved in Japan for HER2-Mutated Metastatic NSCLC

August 23rd 2023

Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.

FDA Grants Priority Review to Enzalutamide for nmCSPC With High-Risk Biochemical Recurrence

August 23rd 2023

The FDA has accepted and granted priority review to a supplemental new drug application seeking the approval of enzalutamide in patients with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence.

Adjuvant Nivolumab Approved in Europe for Completely Resected Stage IIB or IIC Melanoma

August 22nd 2023

The European Commission has approved single-agent nivolumab for use in the adjuvant treatment of adult and adolescent patients aged 12 years or older who have stage IIB or IIC melanoma and who have undergone complete resection.

Selpercatinib Significantly Improves PFS Over MKIs in RET-Mutant Medullary Thyroid Cancer

August 22nd 2023

Selpercatinib demonstrated a statistically significant improvement in progression-free survival vs physician’s choice of cabozantinib or vandetanib in patients with advanced or metastatic RET-mutant medullary thyroid cancer, meeting the primary end point of the phase 3 LIBRETTO-531 trial.

Adjuvant Furmonertinib Shows Efficacy, Tolerability in EGFR+ NSCLC With High-Risk Factors

August 20th 2023

Furmonertinib had efficacy and an acceptable toxicity profile when utilized as adjuvant treatment in EGFR-mutated, stage IA2-IIIA non–small cell lung cancer with high-risk pathological factors who have undergone radical surgery

Ociperlimab Plus Tislelizumab/Chemo Has Antitumor Activity in Stage IV Gastric/GEJ Cancers

August 18th 2023

The combination of ociperlimab, tislelizumab, and chemotherapy elicited responses in patients with stage IV gastric or gastroesophageal junction cancer, irrespective of PD-L1 expression.

Berubicin Demonstrates Early Promise in Recurrent or Refractory Glioblastoma Multiforme

August 15th 2023

Berubicin was found to have acceptable tolerability when administered as second-line treatment in patients with recurrent or refractory glioblastoma multiforme.

FDA Approves HEPZATO KIT for Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

August 15th 2023

The FDA has approved HEPZATO KIT (melphalan/Hepatic Delivery System) for use in the treatment of select patients with unresectable hepatic-dominant metastatic uveal melanoma.

FDA Approves Companion Diagnostic for Niraparib Plus Abiraterone Acetate in BRCA+ mCRPC

August 14th 2023

The FDA has approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet of niraparib plus abiraterone acetate, which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.

FDA Approves Elranatamab for Relapsed or Refractory Multiple Myeloma

August 14th 2023

The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

IBI322 Shows Early Antitumor Efficacy in PD-1/PD-L1–Resistant Classical Hodgkin Lymphoma

August 13th 2023

Single-agent IBI322 elicited responses with favorable safety in patients with classical Hodgkin lymphoma that had become resistant to anti–PD-1/PD-L1 therapy, according to data from a phase 1 trial.

Ofranergene Obadenovec Plus Paclitaxel Misses the Mark in Platinum-Resistant Ovarian Cancer

August 11th 2023

The addition of ofranergene obadenovec to paclitaxel failed to significantly improve survival outcomes compared with paclitaxel alone in patients with platinum-resistant ovarian cancer.

FDA Grants Regular Approval to Pralsetinib for Metastatic RET Fusion+ NSCLC

August 9th 2023

The FDA has granted regular approval to pralsetinib (Gavreto) for adult patients with metastatic RET fusion–positive non–small cell lung cancer, as detected by an FDA-approved test.

FDA Awards Orphan Drug Designation to LSTA1 for Malignant Glioma

August 8th 2023

The FDA has granted orphan drug designation to LSTA1 for use as a potential therapeutic option in patients with malignant glioma, according to an announcement from Lisata Therapeutics, Inc.

FDA Green Lights Companion Diagnostic for Avapritinib in Gastrointestinal Stromal Tumors

August 8th 2023

The FDA has approved the therascreen PDGFRA RGQ PCR kit for use as a companion diagnostic, co-developed by Qiagen and Blueprint Medicines, to assist in the identification of patients with gastrointestinal stromal tumors who may be candidates to receive avapritinib.