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 Grants Accelerated Approval to Ponatinib Plus Chemo for Newly Diagnosed Ph+ ALL

March 19th 2024

The FDA has granted accelerated approval to ponatinib (Iclusig) in combination with chemotherapy for the treatment of adult patients with newly diagnosed, Philadelphia chromosome–positive acute lymphoblastic leukemia.

FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory CLL or SLL

March 15th 2024

The FDA has granted accelerated approval to lisocabtagene maraleucel for the treatment of select patients with relapsed/refractory CLL or SLL.

FDA Approves Tislelizumab for Advanced or Metastatic ESCC After Chemotherapy

March 14th 2024

The FDA has approved tislelizumab-jsgr (Tevimbra) for single-agent use in adult patients with unresectable or metastatic esophageal squamous cell carcinoma following prior systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor.

European Medicines Agency Grants Orphan Drug Designation to Tinengotinib for Biliary Tract Cancer

March 11th 2024

Tinengotinib has been awarded orphan drug designation from the European Medicines Agency for use in select patients with biliary tract cancer.

FDA's MIDAC Votes in Support of Benefit-Risk Profile of Lumisight Optical Imaging Agent for Breast Cancer Detection

March 9th 2024

The FDA's Medical Imaging Drugs Advisory Committee voted 16 to 2 in support of the benefit-risk profile of Lumisight.

FDA Awards Orphan Drug Designation to Cambritaxestat for Pancreatic Cancer

March 8th 2024

Cambritaxestat has received orphan drug designation from the FDA for the treatment of patients with pancreatic cancer.

FDA Approves Frontline Nivolumab Plus Chemo for Unresectable or Metastatic Urothelial Carcinoma

March 7th 2024

The FDA has approved nivolumab plus cisplatin and gemcitabine for first-line use in adult patients with unresectable or metastatic urothelial carcinoma.

FDA Approves Inotuzumab Ozogamicin for Pediatric CD22+ B-Cell Precursor Acute Lymphoblastic Leukemia

March 6th 2024

The FDA has approved inotuzumab ozogamicin for pediatric patients with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

FDA Approves Frontline Amivantamab Plus Chemo for EGFR Exon 20 Insertion+ NSCLC

March 1st 2024

The FDA has approved amivantamab plus chemotherapy for the frontline treatment of select patients with EGFR exon 20 insertion+ non–small cell lung cancer.

FDA Approval Highlights: OncLive’s February Recap

February 29th 2024

In case you missed it, below is a recap of all drugs that have been approved by the FDA in February 2024.

Liso-Cel Demonstrates Durable Efficacy in Relapsed/Refractory CLL/SLL

February 23rd 2024

Lisocabtagene maraleucel elicited durable responses in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

FDA Grants Orphan Drug Designation to Ocifisertib for Acute Myeloid Leukemia

February 21st 2024

The FDA granted an orphan drug designation to ocifisertib for use as a potential therapeutic option in patients with acute myeloid leukemia.

RATIONALE-315 Data Support Perioperative Tislelizumab Plus Chemo in Resectable NSCLC

February 20th 2024

Neoadjuvant tislelizumab plus platinum-based doublet chemotherapy followed by surgery and adjuvant tislelizumab demonstrated efficacy in resectable non–small cell lung cancer.

FDA Approves Osimertinib Plus Chemo for EGFR-Mutated NSCLC

February 16th 2024

The FDA has approved osimertinib (Tagrisso) plus chemotherapy for use in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.

FDA Approves Lifileucel for Unresectable or Metastatic Melanoma

February 16th 2024

The FDA has approved lifileucel suspension (Amtagvi) for adult patients with unresectable or metastatic melanoma following prior treatment with a PD-1 inhibitor, and if BRAF V600 mutation positive, a BRAF inhibitor, with or without a MEK inhibitor.

FDA Approves Tepotinib for Metastatic NSCLC Harboring MET Exon 14 Skipping Alterations

February 15th 2024

The FDA has granted approval to tepotinib (Tepmetko) for adult patients with metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

FDA Approves Frontline NALIRIFOX for Metastatic Pancreatic Adenocarcinoma

February 13th 2024

The FDA has approved irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin, for the frontline treatment of metastatic pancreatic adenocarcinoma.

Long-Term CheckMate 238 Data Support Adjuvant Nivolumab Vs Ipilimumab in Resected Melanoma

February 13th 2024

Adjuvant nivolumab significantly improved relapse-free survival vs ipilimumab in resected stage III/IV melanoma, according to 7-year minimum follow-up.

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

February 9th 2024

The EMA is evaluating a Type II extension of indication application for the approval of first-line amivantamab plus lazertinib in EGFR-mutated NSCLC.

European Commission Grants Orphan Drug Designation to NXC-201 for AL Amyloidosis

February 8th 2024

NXC-201 has received orphan drug designation from the European Commission for use in patients with amyloid light-chain amyloidosis.