Kristi Rosa


FDA Authorizes Marketing of First AI Device to Detect Signs of Colon Cancer

April 12th 2021

The FDA has authorized the marketing of the first device that utilizes artificial intelligence based on machine learning to help clinicians detect lesions like polyps or suspected tumors in the colon in real time during a colonoscopy.

Tislelizumab/Sitravatinib Shows Early Antitumor Activity, Safety in Platinum-Resistant Epithelial Ovarian Cancer

April 11th 2021

The combination of tislelizumab and sitravatinib demonstrated early antitumor activity and a manageable safety profile in patients with recurrent platinum-resistant epithelial ovarian cancer and were naïve to PD-1/PD-L1 inhibition.

Zenocutuzumab Demonstrates Efficacy in Blocking Growth of NRG1 Fusion–Driven Tumors

April 10th 2021

Zenocutuzumab has been shown to block the growth and cause the death of NRG1 fusion–positive cell lines, and to induce tumor shrinkage and durable tumor regression in multiple cancers when used in NRG1 fusion–positive patient-derived xenografts.

Frontline Tebentafusp Significantly Improves OS in Metastatic Uveal Melanoma

April 10th 2021

Tebentafusp (IMCgp100) resulted in a highly significant and clinically meaningful improvement in overall survival when given as a frontline treatment in patients with metastatic uveal melanoma.

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

April 9th 2021

The FDA has granted a priority review to the biologics license application for tisotumab vedotin as a potential treatment for patients with recurrent or metastatic cervical cancer with progressive disease on, or following, chemotherapy.

Daratumumab Consolidation Appears Safe, Shows Encouraging Efficacy in Very Good Responders With Myeloma

April 9th 2021

Daratumumab appears to be safe when used as consolidation therapy in patients with multiple myeloma, even soon after autologous stem cell transplant, and the agent has also demonstrated early efficacy in the setting of very good responders.

Pirtobrutinib Showcases Encouraging Activity in CLL, MCL, and Other B-Cell Malignancies

April 8th 2021

Pirtobrutinib showcased encouraging efficacy with an acceptable safety profile in patients with chronic lymphocytic leukemia or small lymphocytic leukemia, mantle cell lymphoma, and Waldenström macroglobulinemia who previously received a BTK inhibitor.

FDA Grants Fast Track Status to Eftilagimod Alpha for Frontline Recurrent/Metastatic Head and Neck Cancer

April 8th 2021

The FDA has granted a fast track designation to the soluble LAG-3 protein eftilagimod alpha for use in the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

Adjuvant Pembrolizumab Demonstrates Superior DFS Over Placebo in Post-Nephrectomy RCC

April 8th 2021

Single-agent pembrolizumab resulted in a significant improvement in disease-free survival when used as an adjuvant treatment in patients with renal cell carcinoma following nephrectomy or nephrectomy and resection of metastatic lesions, meeting the primary end point of the phase 3 KEYNOTE-564 trial.

Nivolumab-Based Combos Show Superior Survival Benefit Over Chemo in Unresectable Advanced or Metastatic ESCC

April 8th 2021

The combination of nivolumab and ipilimumab and nivolumab plus chemotherapy resulted in a statistically significant overall survival benefit compared with chemotherapy alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.