Almonertinib Approved in China for EGFR T79M+ NSCLC
March 19th 2020The Chinese National Medical Products Administration has approved almonertinib (Ameile; HS-10296) for the treatment of patients with EGFR T790M mutation–positive non–small cell lung cancer who have progressed on or after other EGFR TKI therapy.
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Durvalumab/Chemo OS Benefit Sustained in ES-SCLC, But Durvalumab/Tremelimumab Regimen Falls Short
March 17th 2020Combining durvalumab with standard frontline chemotherapies showed a sustained overall survival benefit in patients with extensive-stage small cell lung cancer, but a regimen of durvalumab, chemotherapy, and tremelimumab did not boost OS.
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Niraparib Takes Step Toward Chinese Approval for Frontline Maintenance in Ovarian Cancer
March 16th 2020The China National Medical Products Administration has accepted a supplemental New Drug Application for niraparib for use as a frontline maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
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Frontline Avelumab Falls Short in Phase III Head and Neck Cancer Study
March 13th 2020The phase III JAVELIN Head and Neck 100 trial has been terminated after an interim analysis showed that the addition of avelumab to standard-of-care chemoradiotherapy was unlikely to lead to a statistically significant improvement in progression-free survival in patients with untreated locally advanced squamous cell carcinoma of the head and neck.
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FDA Grants Balstilimab/Zalifrelimab Dual Immunotherapy Fast Track Designation in Cervical Cancer
March 13th 2020The FDA has granted a Fast Track designation to the combination of the PD-1 inhibitor balstilimab and the CTLA-inhibitor zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer.
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FDA Approves Cytology Test to Enhance Cervical Cancer Prevention
March 11th 2020The FDA has approved the CINtec PLUS Cytology test as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus using the cobas 4800 HPV Test.
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Adjuvant Chemotherapy Shows Strong Benefit in Upper Tract Urothelial Carcinoma
March 7th 2020Adjuvant platinum-based chemotherapy reduced the risk of disease recurrence or death by 55% in patients with upper tract urothelial carcinoma, according to findings from the phase III POUT trial that have now been published in The Lancet.
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Mayo Researchers: Change NCCN Criteria to Expand Genetic Testing in Breast Cancer
March 6th 2020Researchers at the Mayo Clinic maintain that all women aged 65 or under with a breast cancer diagnosis should receive germline genetic testing to identify harmful mutations that increase their risk of developing secondary cancers.
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Brigatinib Nears EU Approval for Frontline ALK+ NSCLC
March 2nd 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for brigatinib for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer
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Venetoclax Combo Misses OS Endpoint in Phase III Frontline AML Trial
March 2nd 2020Combining venetoclax with low-dose cytarabine (LDAC) did not lead to a statistically significant improvement in overall survival compared with LDAC alone in newly-diagnosed patients with acute myeloid leukemia who are ineligible for intensive chemotherapy, according to findings from the phase III VIALE-C (M16-043) trial.
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Deep Data Dive Needed for Upfront Treatment Selection in iNHL
February 29th 2020At the 24th Annual International Congress on Hematologic Malignancies®, Sonali M. Smith, MD, detailed the critical clinical trial findings currently informing treatment selection in the frontline indolent non-Hodgkin lymphoma paradigm.
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FDA Accepts BLA for Subcutaneous Fixed-Dose Pertuzumab/Trastuzumab in HER2+ Breast Cancer
February 25th 2020The FDA has accepted a Biologics License Application for a fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.
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FDA Accepts Niraparib Application for Frontline Maintenance in Ovarian Cancer
February 24th 2020The FDA has accepted a supplemental New Drug Application for niraparib for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.
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FDA Grants Priority Review to Tazemetostat in Follicular Lymphoma
February 14th 2020The FDA has granted a priority review designation to a supplemental new drug application for tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy.
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FDA Grants Priority Review to Cedazuridine/Decitabine for MDS and CMML
February 14th 2020The FDA has granted a priority review designation to a new drug application for cedazuridine plus decitabine for the treatment of adult patients with previously untreated intermediate- and high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia.
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FDA Grants Priority Review to Tucatinib in HER2+ Breast Cancer
February 13th 2020The FDA has granted a priority review designation to a new drug application for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, following at least 3 prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant, or metastatic setting.
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FDA Approval Sought for Daratumumab Plus Carfilzomib/Dexamethasone in Relapsed/Refractory Myeloma
February 11th 2020A supplemental Biologics License Application has been submitted to the FDA for daratumumab for use in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma.
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FDA Grants Priority Review to Capmatinib in METex14+ NSCLC
February 11th 2020The FDA has granted a priority review designation to a new drug application for capmatinib for use as treatment for newly diagnosed and previously treated patients with locally advanced or metastatic MET exon14 skipping—mutated non–small cell lung cancer.
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Trastuzumab Deruxtecan Improves Survival in Heavily Pretreated HER2+ Gastric/GEJ Cancer
January 28th 2020Trastuzumab deruxtecan (Enhertu) improved overall survival versus chemotherapy in patients with heavily pretreated unresectable or metastatic HER2-positive gastric or gastroesophageal junction cancer.
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FDA Approval Sought for Tucatinib in HER2+ Breast Cancer
December 23rd 2019A new drug application has been submitted to the FDA for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
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