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 Orphan Drug Designation to Pimicotinib for Inoperable TGCT

January 15th 2024

The European Medicines Agency has granted orphan drug designation to pimicotinib for use in patients with inoperable tenosynovial giant cell tumor.

EU Approval Sought for Frontline Lazertinib Plus Amivantamab in EGFR+ NSCLC

January 15th 2024

An MAA seeking the approval of lazertinib plus amivantamab in the first-line treatment of adult patients with EGFR+ NSCLC has been submitted to the EMA.

FDA Approves Pembrolizumab Plus Chemoradiation for FIGO 2014 Stage III to IVA Cervical Cancer

January 12th 2024

The FDA has approved pembrolizumab (Keytruda) plus chemoradiation for patients with FIGO 2014 stage III to IVA cervical cancer.

FDA Grants Fast Track Status to SLS009 for Relapsed/Refractory Acute Myeloid Leukemia

January 10th 2024

The FDA has granted fast track designation to SLS009 for use in patients with relapsed or refractory acute myeloid leukemia.

Adagrasib Approved in Europe for Pretreated KRAS G12C+ Advanced NSCLC

January 10th 2024

The European Commission has granted conditional marketing authorization to adagrasib for patients with KRAS G12C+ advanced non–small cell lung cancer.

FDA Grants Priority Review to Tisotumab Vedotin sBLA for Recurrent or Metastatic Cervical Cancer

January 9th 2024

The FDA has granted priority review to a sBLA seeking to convert the accelerated approval of tisotumab vedotin to full approval in select patients with cervical cancer.

NMPA Approval Sought for Frontline Cadonilimab Plus Chemo in Gastric or GEJ Adenocarcinoma

January 8th 2024

China’s NMPA has accepted the sNDA seeking the approval of cadonilimab plus chemotherapy for use in select patients with gastric or GEJ adenocarcinomas.

FDA Grants Breakthrough Therapy Designation to TAR-200 for BCG-Unresponsive High-Risk NMIBC

January 5th 2024

The FDA has granted breakthrough therapy designation to TAR-200 for use in the treatment of patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle invasive bladder cancer who are not candidates for or opted not to receive radical cystectomy.

LUMINANCE Data Support the Frontline Use of Durvalumab Plus Platinum/Etoposide in ES-SCLC

January 4th 2024

The safety and efficacy data observed with the administration of 5 or more cycles of induction platinum/etoposide and concurrent durvalumab in patients with extensive-stage small cell lung cancer enrolled in the phase 3b LUMINANCE study aligned with outcomes reported in the phase 3 CASPIAN trial.

FDA Grants Fast Track, Breakthrough Therapy Designations to Cretostimogene Grenadenorepvec for NMIBC

January 3rd 2024

The FDA has granted fast track and breakthrough therapy designations to cretostimogene grenadenorepvec for use as a potential therapeutic option in patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.

Vibostolimab Plus Pembrolizumab Coformulation ± Docetaxel Did Not Significantly Improve PFS in NSCLC

January 3rd 2024

A coformulation of vibostolimab and pembrolizumab with or without docetaxel failed to result in a statistically significant improvement in progression-free survival compared with docetaxel alone in patients with metastatic non–small cell lung cancer.

EMA Validates MAA for Repotrectinib in ROS1+ NSCLC and NTRK+ Solid Tumors

January 3rd 2024

The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors.

FDA Grants Fast Track Status to Aglatimagene Besadenovec Plus Valacyclovir for Pancreatic Cancer

January 2nd 2024

The FDA has granted fast track designation to aglatimagene besadenovec plus valacyclovir for use as a potential therapeutic option in patients with pancreatic ductal adenocarcinoma.

Sugemalimab Plus Chemo Receives Approval in China for Esophageal Squamous Cell Carcinoma

January 2nd 2024

The National Medical Products Administration of China has approved sugemalimab paired with fluorouracil and platinum-based chemotherapy for use in the frontline treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Markman Shares Hopes for 2024, Underscoring Need for Meaningful Decision Support Across Oncology

December 28th 2023

Maurie Markman, MD, discusses current challenges faced with developing robust decision support tools for oncologists and projects additional research efforts dedicated to finding a way to leverage CAR T-cell therapies in solid tumors to improve patient outcomes.

European Commission Approves New Frontline Indications for Pembrolizumab Plus Chemo in Select GI Cancers

December 21st 2023

The European Commission has approved new indications for pembrolizumab in combination with chemotherapy in select patients with gastric or gastroesophageal adenocarcinoma and select patients with biliary tract cancer.

177Lu-PNT2002 Significantly Improves rPFS Vs ARPI in Metastatic Castration-Resistant Prostate Cancer

December 20th 2023

Treatment with 177Lu-PNT2002 resulted in a significant improvement in radiographic progression-free survival vs abiraterone acetate or enzalutamide in patients with metastatic castration-resistant prostate cancer whose disease had progressed on an androgen receptor pathway inhibitor.

Dostarlimab Plus Chemo Followed by Dostarlimab/Niraparib Improves PFS in Endometrial Cancer

December 20th 2023

Dostarlimab plus carboplatin and paclitaxel, followed by maintenance dostarlimab and niraparib, significantly improved PFS vs placebo plus chemotherapy followed by placebo in patients with primary advanced or recurrent endometrial cancer, according to data from the phase 3 RUBY trial.

Acalabrutinib Triplet Shows Early Signals of Activity, Safety in R/R Mantle Cell Lymphoma

December 19th 2023

The combination regimen comprised of acalabrutinib, venetoclax, and obinutuzumab proved to be safe and feasible and to elicit responses in patients with high-risk, relapsed or refractory mantle cell lymphoma.

Relma-Cel Continues to Elicit Responses in Chinese Patients With R/R Mantle Cell Lymphoma

December 19th 2023

Relmacabtagene autoleucel continued to induce responses with acceptable tolerability in Chinese patients with relapsed or refractory mantle cell lymphoma.