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 Approves Encorafenib Plus Binimetinib for BRAF V600E+ Metastatic NSCLC

October 11th 2023

The FDA has approved encorafenib (Braftovi) plus binimetinib (Mektovi) for adult patients with metastatic non–small cell lung cancer harboring a BRAF V600E mutation, as detected by an FDA-approved test.

Bexmarilimab Plus SOC Continues to Elicit Responses in R/R AML and HMA-Refractory MDS

October 11th 2023

The addition of bexmarilimab to standard-of-care azacitidine or azacitidine plus venetoclax continued to elicit responses in patients with relapsed or refractory acute myeloid leukemia and those with myelodysplastic syndrome who were refractory to hypomethylating agents.

TJ-L14B/ABL503 Showcases Early Efficacy Signals in Advanced or Metastatic Solid Tumors

October 10th 2023

TJ-L14B/ABL503 demonstrated preliminary efficacy signals in the form of responses in patients with progressive, locally advanced or metastatic solid tumors who were relapsed or refractory after previous lines of therapy.

Perioperative Pembrolizumab Meets Dual Primary End Point of OS in NSCLC

October 10th 2023

Pembrolizumab plus chemotherapy prior to surgery, followed by resection and single-agent pembrolizumab in the adjuvant setting, significantly improved overall survival vs neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in patients with resectable stage II, IIIA, or IIIB (T3-4N2) non–small cell lung cancer, meeting the dual primary end point of the phase 3 KEYNOTE-671 trial.

Continued Maintenance With Obinutuzumab Plus Acalabrutinib/Venetoclax Boosts uMRD Rate in R/R CLL

October 9th 2023

The undetectable minimal residual disease ate achieved with bendamustine followed by obinutuzumab, acalabrutinib, and venetoclax increased as the regimen was continued as maintenance treatment in patients with relapsed or refractory chronic lymphocytic leukemia.

Venetoclax Plus Dexamethasone Misses PFS End Point in t(11;14)+ R/R Multiple Myeloma

October 9th 2023

The combination of venetoclax and dexamethasone failed to significantly improve progression-free survival over pomalidomide plus dexamethasone in patients with t(11;14)-positive, relapsed or refractory multiple myeloma who have previously received at least 2 therapies.

European Approval Sought for Amivantamab Plus Chemo in EGFR Exon 20 Insertion+ NSCLC

October 6th 2023

A Type II extension of indication application seeking the approval of amivantamab in combination with carboplatin and pemetrexed for the frontline treatment of adult patients with advanced non–small cell lung cancer and activating EGFR exon 20 insertion mutations has been submitted to the European Medicines Agency.

BLA Resubmitted to FDA for On-Body Injector Presentation of Pegfilgrastim-cbqv

October 5th 2023

The biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, a biosimilar of pegfilgrastim, has been resubmitted to the FDA for review.

SABR to Oligoprogressive Lesions Delays Systemic Therapy Change in ER+ Advanced Breast Cancer

October 5th 2023

Administration of stereotactic ablative body radiotherapy to oligoprogressive lesions delayed a change in systemic therapy in patients with estrogen receptor–positive/HER2-negative breast cancer enrolled to the prospective phase 2 AVATAR trial.

EMA Validates MAA for Imetelstat for Transfusion-Dependent Anemia in Lower-Risk MDS

October 3rd 2023

The European Medicines Agency has validated the marketing authorization application for the use of imetelstat in the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndrome.

Takeda to Voluntarily Withdraw Mobocertinib for EGFR Exon 20 Insertion+ NSCLC

October 2nd 2023

Takeda has announced plans to voluntarily withdraw mobocertinib in the United States for adult patients with EGFR exon 20 insertion mutation–positive, locally advanced or metastatic non–small cell lung cancer whose disease has progressed on or following platinum-based chemotherapy.

Japanese Approval Sought for Fruquintinib in Previously Treated Metastatic Colorectal Cancer

October 2nd 2023

A new drug application seeking the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer has been submitted to Japan’s Ministry of Health, Labour, and Welfare.

IberVd Elicits Durable Responses in Transplant-Ineligible, Newly Diagnosed Multiple Myeloma

September 29th 2023

The combination of iberdomide plus bortezomib and dexamethasone produced deep responses with a manageable toxicity profile in patients with transplant-ineligible, newly diagnosed multiple myeloma, according to data from the phase 1/2 CC-220-MM-001 trial presented at the 2023 International Myeloma Society Annual Meeting.

FDA Grants Fast Track Designation to IDE161 for Select Pretreated BRCA1/2-Mutated HR+ Breast Cancer

September 27th 2023

The FDA has granted fast track designation to IDE161 for use in adult patients with advanced or metastatic hormone receptor–positive, HER2-negative breast cancer harboring BRCA1/2 mutations who have progressed after at least 1 hormonal therapy, a CDK4/6 inhibitor, and a PARP inhibitor.

Gilead Discontinues Phase 3 ENHANCE-2 Trial of Magrolimab Plus Azacitidine in TP53-Mutant AML

September 27th 2023

The phase 3 ENHANCE-2 trial examining the frontline combination of magrolimab and azacitidine vs physician’s choice of venetoclax with azacitidine or intensive chemotherapy in patients with acute myeloid leukemia and TP53 mutations has been discontinued, according to an announcement from Gilead Sciences.

FDA Grants Fast Track Status to MYTX-011 for NSCLC With cMET Overexpression

September 26th 2023

The FDA has granted fast track designation to MYTX-011 for use as a potential therapeutic option in patients with non–small cell lung cancer and cMET overexpression.

Epcoritamab Wins European and Japanese Approval for Select Types of R/R LBCL

September 25th 2023

Epcoritamab-bysp has been approved by the European Commission and Japan's Ministry of Health, Labour, and Welfare for the treatment of select patients with relapsed/refractory large B-cell lymphoma.

FDA Issues CRL to BLA for On-Body Injector Presentation of Pegfilgrastim-cbqv

September 25th 2023

The FDA has issued a complete response letter to the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, which is a biosimilar of pegfilgrastim.

MWTX-003 Wins FDA Fast Track Designation for Polycythemia Vera

September 21st 2023

The FDA has granted fast track designation to the investigational, anti-TMPRSS6 monoclonal antibody, MWTX-003 (DISC-3405), for use in the treatment of patients with polycythemia vera, according to an announcement from Disc Medicine, Inc.

FDA Approval Sought for Frontline Tislelizumab in Locally Advanced or Metastatic ESCC

September 19th 2023

The FDA has accepted for review a biologics license application seeking the approval of tislelizumab for use in the frontline treatment of patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma.