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
Sequential Combo of Regorafenib and Nivolumab Shows Manageable Safety in Sorafenib-Pretreated HCC
September 6th 2022The sequential treatment of regorafenib followed by nivolumab was found to have an acceptable toxicity profile in patients with hepatocellular carcinoma who progressed on and tolerated first-line sorafenib, according to early data from the phase 1/2a GOING trial.
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Approval Sought for Tafasitamab/Lenalidomide Combo in R/R DLBCL in Hong Kong
August 31st 2022The Hong Kong Special Administrative Region’s Department of Health has accepted for review a biologics license application seeking the approval of tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma.
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The addition of daratumumab to lenalidomide, bortezomib, and dexamethasone (RVd) induction and consolidation treatment and lenalidomide maintenance therapy (D-RVd/D-R) resulted in high minimal residual disease rates and prolonged progression-free survival in patients with transplant-eligible, newly diagnosed multiple myeloma.
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FDA Approval Sought for Lifileucel in Advanced Melanoma
August 25th 2022A rolling biologics license application has been submitted to the FDA seeking the approval of lifileucel in patients with advanced melanoma who progressed on or after previous anti–PD-1/PD-L1 therapy, and if BRAF mutation positive, also previous BRAF or BRAF/MEK inhibitor therapy.
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European Commission Grants Conditional Marketing Authorization to Teclistamab for Multiple Myeloma
August 24th 2022The European Commission has granted conditional marketing authorization to teclistamab for use as a single agent in adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
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Tislelizumab/Chemo Combo Takes Step Toward Chinese Approval for Unresectable ESCC
August 23rd 2022The China National Medical Products Administration’s Center for Drug Evaluation has accepted for review a supplemental biologics application seeking the approval of tislelizumab plus chemotherapy in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.
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FDA Grants Breakthrough Therapy Designation to Taletrectinib for ROS1+ NSCLC
August 23rd 2022The FDA has granted a breakthrough therapy designation to taletrectinib for use as a potential therapeutic option in adult patients with advanced or metastatic ROS1-positive non–small cell lung cancer who were ROS1 inhibitor naïve or who previously received crizotinib.
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Bevacizumab Biosimilar CT-P16 Approved in Europe for Multiple Cancer Types
August 19th 2022The European Commission has approved the bevacizumab biosimilar, CT-P16, for the treatment of patients with metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.
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The United Kingdom Medicines and Healthcare Products Regulatory Agency has extended the conditional marketing authorization of fam-trastuzumab deruxtecan-nxki for single-agent use in adult patients in Great Britain who have HER2-positive unresectable or metastatic breast cancer and have received 1 or more prior HER2-based regimens.
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The combination of lenalidomide and rituximab demonstrated durable safety and efficacy that was comparable to that achieved with rituximab plus chemotherapy in previously untreated patients with follicular lymphoma, according to 6-year data from the phase 3 RELEVANCE trial.
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Ruxolitinib/Pomalidomide Combo Shows Feasibility in Myelofibrosis With Anemia
August 16th 2022A combination regimen comprised of ruxolitinib and pomalidomide was found to be safe and feasible in a cohort of intermediate-2 and high-risk patients with primary or secondary myelofibrosis and anemia, according to data from the phase 1b/2 MPNSG-0212 trial.
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Nivolumab/Ipilimumab Combo Provides Long-Term Survival Benefit in Advanced HCC After Sorafenib
August 13th 2022The dual immunotherapy combination comprised of nivolumab given at 1 mg/kg and ipilimumab given at 3 mg/kg provided durable responses and long-term survival benefit in patients with advanced hepatocellular carcinoma following treatment with sorafenib.
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FDA Approves Trastuzumab Deruxtecan for HER2-Mutant NSCLC
August 11th 2022The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic non–small cell lung cancer whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received previous systemic therapy.
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FDA Grants Regular Approval to Capmatinib for METex14+ NSCLC
August 11th 2022The FDA has granted regular approval to capmatinib (Tabrecta) for adult patients with metastatic non–small cell lung cancer whose tumors have a mutation leading to MET exon 14 skipping, as detected by an FDA-approved test.
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FDA Grants Priority Review to Elacestrant for ER+/HER2- Advanced or Metastatic Breast Cancer
August 11th 2022The FDA has granted priority review to a new drug application seeking the approval of elacestrant for use in patients with estrogen receptor–positive/HER2-negative advanced or metastatic breast cancer.
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Although frontline treatment with avelumab resulted in a longer overall survival and progression-free survival than that observed with platinum-based chemotherapy in patients with advanced non–small cell lung cancer and high PD-L1 positivity, this difference did not achieve statistical significance.
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Frontline Tislelizumab Proves Noninferior to Sorafenib for OS in Unresectable HCC
August 9th 2022First-line treatment with tislelizumab was found to result in a noninferior overall survival benefit to that achieved with sorafenib in adult patients with unresectable hepatocellular carcinoma, meeting the primary end point of the phase 3 RATIONALE 301 trial.
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Talazoparib Plus Low-Dose Temozolomide Improves ORR Over Historical Control in R/R ES-SCLC
August 8th 2022The combination of talazoparib and temozolomide elicited an objective response rate of 39.3% in patients with extensive-stage small cell lung cancer who were relapsed or refractory to a frontline platinum-based chemotherapy regimen, according to data from a phase 2 UCLA/TRIO-US L-07 trial.
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