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

Gilead Discontinues Phase 3 ENHANCE-3 Trial of Magrolimab Plus Venetoclax/Azacitidine in AML

February 8th 2024

The phase 3 ENHANCE-3 study of magrolimab plus venetoclax/azacitidine vs venetoclax/azacitidine in select patients with AML has been terminated.

Regulatory Filings Accepted for Perioperative Nivolumab Plus Chemotherapy in NSCLC

February 7th 2024

The FDA and EMA have accepted applications seeking the approval of neoadjuvant nivolumab/chemotherapy followed by surgery and adjuvant nivolumab in NSCLC.

Second-Line Fruquintinib Plus Paclitaxel Significantly Improves PFS But Not OS in Advanced Gastric or GEJ Adenocarcinoma

February 6th 2024

Fruquintinib/paclitaxel significantly improved PFS but not OS vs paclitaxel alone in the second-line treatment in patients with advanced gastric cancer.

FDA Grants Fast Track Status to Vepdegestrant for ER+/HER2– Metastatic Breast Cancer

February 6th 2024

Vepdegestrant has received FDA fast track designation for select patients with ER-positive/HER2-negative locally advanced or metastatic breast cancer.

Tinengotinib Shows Early Tolerability, Efficacy Signals in Heavily Pretreated mCRPC

February 5th 2024

Tinengotinib elicited responses with a manageable safety profile in heavily pretreated patients with metastatic castration-resistant prostate cancer.

Health Canada Slated to Review New Drug Submission for Momelotinib in Myelofibrosis

February 5th 2024

Health Canada will review the new drug submission seeking the approval of momelotinib in patients with myelofibrosis.

EMA Validates MAA for Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

February 2nd 2024

The MAA seeking the approval of tisotumab vedotin in select patients with recurrent or metastatic cervical cancer has been validated by the EMA.

FDA Grants Orphan Drug Designation to Efineptakin Alfa for Pancreatic Cancer

February 2nd 2024

Efineptakin alfa received an orphan drug designation from the FDA for use as a potential therapeutic option in patients with pancreatic cancer.

Japanese Approval Sought for Enfortumab Vedotin Plus Pembrolizumab in Urothelial Cancer

February 1st 2024

A sNDA seeking approval of enfortumab vedotin plus pembrolizumab for first-line use in patients with urothelial cancer has been submitted to Japan’s MHLW.

SCO-101 Plus FOLFIRI Shows Signs of Efficacy in Metastatic Colorectal Cancer

February 1st 2024

The combination of SCO-101 and FOLFIRI resulted in tumor reduction and increased progression-free survival in patients with metastatic colorectal cancer.

Ziftomenib Combos Show Early Safety, Activity in NPM1-Mutant and KMT2A-Rearranged AML

January 31st 2024

An acceptable safety profile and early evidence of clinical activity was observed with ziftomenib plus standard regimens in select patients with AML.

FDA Grants Priority Review to Adjuvant Alectinib for Early-Stage ALK+ NSCLC

January 31st 2024

The FDA granted priority review to a sNDA seeking the approval of alectinib as adjuvant treatment after surgery for early-stage ALK-positive NSCLC.

FDA Grants Priority Review to Expand Liso-Cel Indications in R/R Follicular Lymphoma and MCL

January 30th 2024

Liso-cel sBLAs for indications in relapsed/refractory FL and MCL after exposure to a BTK inhibitor have received priority review from the FDA.

Frontline Pembrolizumab Plus Cabozantinib Elicits Responses in Cisplatin-Ineligible Urothelial Carcinoma

January 27th 2024

Pembrolizumab plus cabozantinib was efficacious in the first-line treatment of patients with cisplatin-ineligible urothelial carcinoma.

Idecabtagene Vicleucel Approaches EU Approval in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma

January 26th 2024

The EMA's CHMP has recommended the approval of idecabtagene vicleucel in patients with multiple myeloma who received at least 2 prior therapies.

KVA12123 Showcases Early Tolerability in Advanced Solid Tumors

January 24th 2024

KVA12123 demonstrated early signals of on-target activity and tolerability at all dose levels examined to date in patients with advanced solid tumors.

Obecabtagene Autoleucel BLA for Relapsed/Refractory B-ALL Under FDA Review

January 23rd 2024

The FDA has accepted for review the BLA for obecabtagene autoleucel's use in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

FDA Approves Erdafitinib for FGFR3+ Locally Advanced or Metastatic Urothelial Carcinoma

January 19th 2024

The FDA has approved erdafitinib (Balversa) for select adult patients with locally advanced or metastatic urothelial carcinoma harboring FGFR3 alterations.

Neoadjuvant Durvalumab Plus Chemo Boosts pCR Vs Chemo Alone in Gastric/GEJ Cancers Regardless of Region

January 19th 2024

Durvalumab plus neoadjuvant FLOT improved pCR vs chemotherapy alone in patients with resectable gastric and GEJ cancers, irrespective of region.

FDA Accepts PMA Application Seeking Approval of TTFields Therapy in NSCLC for Filing

January 18th 2024

A PMA application seeking approval of TTFields to standard therapies in patients with non–small cell lung cancer has been accepted for filing by the FDA.