All
Margetuximab Demonstrates Positive PFS Findings in Metastatic HER2+ Breast Cancer
February 7th 2019Patients with heavily pretreated metastatic HER2-positive breast cancer saw an improvement in progression-free survival with margetuximab combined with chemotherapy compared with trastuzumab and chemotherapy, according to findings from the phase III SOPHIA trial.
Caplacizumab-yhdp Approved by FDA For Acquired Thrombotic Thrombocytopenic Purpura
February 7th 2019The first treatment regimen has been approved by the FDA to treat adult patients with acquired thrombocytic thrombocytopenic purpura: the nanobody caplacizumab-yhdp when given in combination with plasma exchange and immunosuppression.
CMS Overlooks Early-Staged Cancer in National Coverage Determination for NGS-Based Testing
February 6th 2019Over 60 healthcare organizations are pressing the Center for Medicare and Medicaid Services to revise its current interpretation of the National Coverage Determination, which they say wrongly excludes germline next-generation sequencing-based testing from Medicare coverage for patients with early-stage cancers.<br />
Pexidartinib Granted Priority Review by FDA for Treatment of Tenosynovial Giant Cell Tumor
February 6th 2019Based on findings from the phase III ENLIVEN study, a new drug application for the investigational, small molecule, CSF1R receptor inhibitor pexidartinib has been granted a priority review by the FDA for the treatment of adult patients with symptomatic tenosynovial giant cell tumor.
Adjuvant T-DM1 Submitted for FDA Approval in High-Risk HER2+ Breast Cancer
February 5th 2019A supplemental Biologics License Application for ado-trastuzumab emtansine (T-DM1; Kadcyla) has been submitted to the FDA seeking approval for the agent as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy.
Survival Benefit With GI-Based Adjuvant Chemotherapy Regimen in Mucinous Ovarian Cancer
February 5th 2019Data from a retrospective study suggests an adjuvant gastrointestinal-based chemotherapy regimen is more beneficial than one that is gynecologic-based in patients with mucinous ovarian cancer, said Katherine C. Kurnit, MD.
Progress in Treating Rare Cancers Named ASCO's Advance of the Year
February 4th 2019In recognition of the many advancements that have been made in the past year toward developing new therapies for patients with difficult-to-treat, rare cancers, ASCO has chosen progress in treating rare cancers as its Advance of the Year.
Expert Discusses Recent Advances With PARP Inhibitors in Ovarian Cancer
February 4th 2019In an interview with <em>Targeted Oncology</em> during the 2019 SGO Annual Winter Meeting, Shannon Westin, MD, discussed the advances seen with PARP inhibitors in ovarian cancer, novel investigational agents, and the importance of molecular testing.
On Recommendation From FDA, No NDA to be Filed for Tivozanib in RCC
February 1st 2019Based on a recommendation from the FDA, Aveo Oncology has decided not to submit a new drug application for tivozanib. The FDA has advised it was not satisfied with the preliminary overall survival data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell carcinoma.
Questions Remain for Targeted Therapy Beyond PARP Inhibition in Ovarian Cancer
February 1st 2019Targeted therapy has effectively been established as an option for patients with ovarian cancers. However, beyond PARP inhibition in the <em>BRCA</em>-mutated or homologous recombination deficient population, questions remain about how to best treat these patients, Ramez N. Eskander, MD, said at the 2019 SGO Annual Winter Meeting.
Apalutamide Trial Hits Primary Endpoints in Metastatic Castration-Sensitive Prostate Cancer
February 1st 2019In topline findings from the phase III TITAN trial announced today by Janssen, apalutamide in combination with androgen deprivation therapy significantly improved radiographic progression-free survival and overall survival versus placebo in patients with metastatic castration-sensitive prostate cancer.
FDA Expands Pemetrexed Indication for Frontline Immunochemotherapy Combo in NSCLC
January 31st 2019Based on data from the phase III KEYNOTE-189 trial, the FDA has expanded the approval for pemetrexed injection in combination with pembrolizumab and platinum-based chemotherapy to include the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer without <em>EGFR</em> or <em>ALK</em> alterations.
Expert Discusses Abemaciclib Monotherapy in HR+/HER2- Breast Cancer
January 30th 2019In findings from the phase II next MONARCH 1 trial, single-agent abemaciclib continued to be safe and effective for patients with hormone receptor–positive, HER2-negative advanced breast cancer who have progressed on or following endocrine therapy.
Positive RET Staining Associated with Low Risk of Recurrence, Death in Thyroid Cancer
January 30th 2019Positive RET staining by immunohistochemistry was associated with a low risk of recurrence and death from papillary thyroid cancer, according to a new exploratory analysis published in <em>Cancer Medicine</em> that examined a cohort of 231 patients with long-term follow up at a single institution.
Brahmer Highlights Immunotherapies in the Pipeline for NSCLC
January 29th 2019During a presentation at the <em>16th Annual </em>Winter Lung Cancer Conference, Julie R. Brahmer, MD, MSc shed light on some of the immunotherapy treatment options that could be entering the lung cancer pipeline over the next 5 years.
Obinutuzumab Lowers Incidence of Disease Progression in Follicular Lymphoma
January 29th 2019According to an exploratory analysis of the GALLIUM trial, obinutuzumab-based chemotherapy resulted in fewer incidences of disease progression compared to rituximab-based chemotherapy in previously untreated patients with advanced follicular lymphoma.