Kristi Rosa

Managing Editor, 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 serves as the main digital news writer for OncLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

Articles

FDA Approves Tisagenlecleucel for Relapsed or Refractory Follicular Lymphoma

May 27th 2022

The FDA has granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

FDA Approves 2 Frontline Nivolumab-Based Regimens for Unresectable Advanced or Metastatic ESCC

May 27th 2022

The FDA has approved nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, irrespective of PD-L1 status.

Polatuzumab Vedotin Plus R-CHP Approved in Europe for Previously Untreated DLBCL

May 26th 2022

The European Commission has approved the combination of polatuzumab vedotin and rituximab and cyclophosphamide, doxorubicin, and prednisone for use in adult patients with previously untreated diffuse large B-cell lymphoma.

FDA Approves Ivosidenib Plus Azacitidine for Newly Diagnosed IDH1-Mutated AML

May 25th 2022

The FDA has approved ivosidenib (Tibsovo) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

FDA Grants Fast Track Status to Seribantumab for Solid Tumors Harboring NRG1 Gene Fusions

May 25th 2022

The FDA has granted a fast track designation to seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene fusions.

Nirogacestat Significantly Improves PFS in Progressing Desmoid Tumors

May 24th 2022

Nirogacestat was found to significantly improve progression-free survival over placebo when used in the treatment of adult patients with progressing desmoid tumors, meeting the primary end point of the phase 3 DeFi trial.

FDA Approval Sought for N-803 Plus BCG in BCG-Unresponsive NMIBC Carcinoma in Situ

May 23rd 2022

A biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin in patients with BCG-unresponsive, non–muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease has been submitted to the FDA.

FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia

May 20th 2022

The FDA has approved azacitidine (Vidaza) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia.

Selinexor Combo Approaches EU Approval for Refractory Multiple Myeloma

May 20th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of selinexor in combination with bortezomib and low-dose dexamethasone for use in adult patients with multiple myeloma who have previously received 1 to 3 prior lines of treatment.

Orteronel Plus ADT Misses OS End Point in Metastatic Hormone-Sensitive Prostate Cancer

May 20th 2022

The addition of orteronel to androgen deprivation therapy vs bicalutamide improved progression-free survival and prostate-specific antigen response in patients with metastatic hormone-sensitive prostate cancer, but missed the primary end point of overall survival in the phase 2 SWOG-1216 trial.

Frontline Datopotamab Deruxtecan/Durvalumab Combo Elicits Encouraging Responses in TNBC

May 19th 2022

The combination of the TROP2-directed antibody-drug conjugate datopotamab deruxtecan and durvalumab showcased early activity with acceptable safety when used as first-line treatment in patients with locally advanced or metastatic triple-negative breast cancer, according to data from the phase 1b/2 BEGONIA trial.

Nivolumab/Ipilimumab Plus SBRT Shows Antitumor Activity in Refractory Pancreatic Cancer

May 18th 2022

Stereotactic body radiation therapy in combination with nivolumab and ipilimumab demonstrated clinically meaningful antitumor activity with a favorable toxicity profile in difficult-to-treat patients with refractory metastatic pancreatic cancer, although the contribution of SBRT is still unclear.

Selinexor Improves PFS, Time to Next Treatment in Advanced, Metastatic Dedifferentiated Liposarcoma

May 18th 2022

Selinexor monotherapy prolonged progression-free survival, time to next treatment, and reduced pain in patients with advanced, refractory dedifferentiated liposarcoma.

Toripalimab Produces Promising Clinical Activity in Metastatic Urothelial Cancer

May 17th 2022

The recombinant humanized anti–PD-1 monoclonal antibody toripalimab elicited an encouraging objective response rate with an acceptable toxicity profile in patients with metastatic urothelial cancer who were refractory to frontline chemotherapy.

Frontline Nivolumab/Ipilimumab Misses OS End Point in PD-L1+ Unresectable or Metastatic Urothelial Carcinoma

May 16th 2022

The combination of nivolumab plus ipilimumab was not found to significantly improve overall survival over standard-of-care chemotherapy when used in the first-line treatment of patients with unresectable or metastatic urothelial carcinoma with a PD-L1 expression of 1% or higher.

Isatuximab Combo Significantly Improves PFS in Relapsed Multiple Myeloma

May 16th 2022

The addition of isatuximab-irfc to carfilzomib and dexamethasone resulted in a significant improvement in progression-free survival vs carfilzomib plus dexamethasone alone in patients with relapsed or refractory multiple myeloma.

Relugolix Shows Acceptable Safety in Patients With Advanced Prostate Cancer Enrolled to HERO Trial

May 14th 2022

Results from a detailed safety analysis of the pivotal phase 3 HERO trial showed that relugolix, an oral gonadotropin-releasing hormone receptor antagonist, had an acceptable toxicity profile with favorable tolerability in patients with advanced prostate cancer.

Frontline Tiragolumab/Atezolizumab Combo Misses PFS End Point in PD-L1–High Metastatic NSCLC

May 11th 2022

The anti-TIGIT immunotherapy tiragolumab in combination with atezolizumab did not improve progression-free survival over atezolizumab alone in the first-line treatment of patients with PD-L1–high locally advanced or metastatic non–small cell lung cancer.

Adjuvant Abemaciclib Plus Endocrine Therapy Has Robust Efficacy in monarchE Cohort of High-Risk, HR+ Breast Cancer

May 6th 2022

The addition of adjuvant abemaciclib to endocrine therapy resulted in a clinically meaningful reduction in the risk of developing invasive disease, particularly incurable distant metastatic disease, in patients with high-risk, hormone receptor–positive, HER2-negative, early breast cancer who comprised cohort 1 of the phase 3 monarchE trial.

CTX-009/Paclitaxel Combo Demonstrates Antitumor Activity, Favorable Tolerability in Biliary Tract Cancer

May 5th 2022

A novel combination comprised of the investigational bispecific antibody CTX-009 and paclitaxel was found to produce responses in 4 subtypes of biliary tract cancer with favorable safety and tolerability, according to interim results from an ongoing phase 2 trial.