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

EMA Grants PRIME Designation to Iopofosine I-131 for Waldenström Macroglobulinemia

September 19th 2023

The European Medicines Agency has granted Priority Medicines designation to iopofosine I-131 for use in patients with Waldenström macroglobulinemia in patients who previously received at least 2 treatment regimens.

Brentuximab Vedotin Plus AVD Gets Positive CHMP Opinion for CD30+ Stage III Hodgkin Lymphoma

September 18th 2023

The European Medicine Agency’s Committee for Medicinal Products for Human Use has recommended the approval of brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine in adult patients with previously untreated, CD30-positive, stage III Hodgkin lymphoma.

FDA Approves Momelotinib for Myelofibrosis With Anemia

September 15th 2023

The FDA has approved momelotinib (Ojjaara) for the treatment of adult patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, and anemia.

Trastuzumab Deruxtecan Receives CHMP Recommendation for Approval in HER2-Mutant NSCLC

September 15th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with HER2-mutated, advanced non–small cell lung cancer who require systemic treatment after platinum-based chemotherapy with or without immunotherapy.

Extended Melphalan Flufenamide Indication Approaches EU Approval for R/R Multiple Myeloma

September 14th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding a Type II variation application to extend the therapeutic indication of melphalan flufenamide for use in adult patients with multiple myeloma who have received at least 2 prior lines of treatment and whose disease is refractory to lenalidomide and the last line of therapy.

FDA Grants Fast Track Status to Tulmimetostat for Endometrial Cancer

September 13th 2023

The FDA has granted fast track designation to tulmimetostat for use as a potential therapeutic option in patients with advanced, recurrent, or metastatic endometrial cancer harboring ARID1A mutations and whose disease had progressed on at least 1 prior line of therapy.

EMA Validates Type II Variation Application for Enzalutamide in Nonmetastatic Hormone-Sensitive Prostate Cancer

September 13th 2023

The European Medicines Agency has validated its Type II variation for enzalutamide as an option in patients with nonmetastatic hormone-sensitive prostate cancer at high risk of biochemical recurrence who are not suitable for salvage radiotherapy.

Neoadjuvant Durvalumab Plus Chemo Followed by Adjuvant Durvalumab Does Not Provide Benefit for EGFR+ NSCLC

September 11th 2023

The addition of durvalumab to chemotherapy prior to surgery, followed by adjuvant durvalumab, did not provide a clear clinical benefit in patients with early-stage non–small cell lung cancer harboring an EGFR mutation, according to data from the phase 3 AEGEAN trial.

Iruplinalkib Improves PFS Vs Crizotinib in Locally Advanced or Metastatic ALK+ NSCLC

September 10th 2023

Treatment with iruplinalkib significantly improved progression-free survival and produced a higher objective response rate compared with crizotinib in patients with ALK TKI–naïve, locally advanced and metastatic ALK-positive non–small cell lung cancer, according to data from a prespecified interim analysis of the phase 3 INSPIRE trial.

Frontline Benmelstobart Plus Anlotinib/Chemo Improves Survival Vs Placebo in ES-SCLC

September 10th 2023

The addition of benmelstobart to anlotinib and etoposide plus carboplatin significantly improved progression-free survival and overall survival over placebo plus etoposide plus carboplatin when used in the first-line treatment of patients with extensive-stage small cell lung cancer.

Subcutaneous Epcoritamab Elicits Durable Responses in Relapsed/Refractory LBCL

September 8th 2023

Subcutaneous epcoritamab produced deep and durable complete remissions in patients with relapsed or refractory large B-cell lymphoma, with complete responders having favorable long-term outcomes, according to updated data from the phase 1/2 EPCORE NHL-1 trial.

Early Cytogenetic or Molecular Landmark Response to Ponatinib Predicts Outcomes in CP-CML

September 7th 2023

Early cytogenetic and molecular responses achieved with ponatinib was significantly linked with better long-term progression-free survival and overall survival in patients with highly resistant, pretreated chronic-phase chronic myeloid leukemia.

FDA Approval Sought for Crovalimab for Paroxysmal Nocturnal Hemoglobinuria

September 6th 2023

The FDA has accepted a biologics license application seeking the approval of crovalimab for use in patients with paroxysmal nocturnal hemoglobinuria.

Acalabrutinib Approved in China for Chronic Lymphocytic Leukemia

September 5th 2023

The National Medical Products Administration in China has approved acalabrutinib for use in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously received at least 1 therapy.

Repotrectinib Gets Breakthrough Therapy Designation in China for NTRK+ TKI-Pretreated Solid Tumors

August 30th 2023

The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.

Savolitinib Wins Breakthrough Therapy Designation in China for Gastric Cancer With MET Amplification

August 30th 2023

The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted a breakthrough therapy designation to savolitinib for use in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction with MET amplification in whom at least 2 lines of standard therapy have failed.

Subcutaneous Atezolizumab Approved in Great Britain for All Intravenous Indications

August 29th 2023

Great Britain’s Medicines and Healthcare Products Regulatory Agency has approved subcutaneous atezolizumab for all indications in which the intravenous formulation of the drug has been approved, including select types of lung, bladder, breast, and liver cancers.

FDA Approves Luspatercept for First-line Treatment of Anemia in Lower-Risk MDS

August 29th 2023

The FDA has approved luspatercept-aamt (Reblozyl) for the treatment of anemia without prior erythropoiesis stimulating agent (ESA) use in adult patients with very low– to intermediate-risk myelodysplastic syndrome (MDS) who may require regular red blood cell (RBC) transfusions.

European Medicines Agency Grants Orphan Drug Designation to Mitazalimab for Pancreatic Cancer

August 25th 2023

The European Medicines Agency has granted orphan drug designation to mitazalimab for use in patients with pancreatic cancer.

FDA Grants Fast Track Status to ALE.C04 for Recurrent or Metastatic CLDN1+ HNSCC

August 25th 2023

The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1–positive head and neck squamous cell carcinomas.