Abemaciclib Triplet Improve PFS in HR+, HER+ Advanced Breast Cancer
June 10th 2020"The endocrine combination of abemaciclib plus fulvestrant and trastuzumab showed significant improvements in both progression-free survival and overall response compared with chemotherapy plus trastuzumab and was generally well-tolerated."
Plinabulin/Pegfilgrastim Improves CIN-Related Outcomes in Patients With Cancer
June 10th 2020"This approach provides potential benefits for both clinicians and patients: clinicians may gain greater control over cancer care, and patients may experience better clinical outcomes and an improved quality of life."
Cirmtuzumab Added to Ibrutinib Induces Responses in R/R MCL and CLL
June 6th 2020Compelling objective responses and safety results were demonstrated with the combination of cirmtuzumab and ibrutinib in cohorts of patients with mantle cell lymphoma and chronic lymphocytic leukemia, who were treated in the phase 1b/2 clinical trial.
Palliative Care Collaboration With Oncology Amplifies During COVID-19 Pandemic
June 5th 2020In an interview with Targeted Oncology, Aberdeen Mehta, MD, MPH, discussed his experiences practicing palliative care in patients with cancer during the COVID-19 pandemic and how new care plans may continue even after the curve flattens.
Amivantamab Generates Activity With Manageable Toxicity in EGFR Exon 20-Mutant NSCLC
June 5th 2020Amivantamab (JNJ-61186372) induced durable responses and demonstrated a manageable safety profile in patients with EGFR exon 20-mutant non–small cell lung cancer (NSCLC), according to results from the phase I CHRYSALIS study (NCT02609776) presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program.
BLA for Ropeginterferon Alfa-2b as PV Treatment Accepted by the FDA
June 4th 2020"We believe ropeginterferon alfa-2b could become an important new therapeutic tool and look forward to engaging with the regulators in our efforts to introduce this option to the underserved PV community in the United States."
Early Data From Tilsotolimod Plus Nivolumab and Ipilimumab Leads to Expansion of MSS-CRC Trial
June 3rd 2020Tilsotolimod has demonstrated innate and adaptive immune activation in multiple tumors. Now, some safety and efficacy data have been reported for the combination of tilsotolimod plus nivolumab and ipilimumab.
High-Dose Osimertinib Shows Limited Benefit in EGFR+ NSCLC With CNS Involvement
June 2nd 2020Treatment with high-dose osimertinib showed positive survival and central nervous system progressive disease control in a real-world cohort of patients with EGFR-mutant non–small cell lung cancer, but these results were not statistically significant.
FDA Grants Priority Review to Naxitamab in R/R High-Risk Neuroblastoma
June 2nd 2020"We believe that the FDA’s acceptance of our BLA for priority review of our first leading antibody compound, naxitamab, is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that naxitamab if approved, can address a significant unmet medical need for [patients] with relapsed/refractory high-risk neuroblastoma."
FDA Accepts NDA for Tivozanib in Relapsed/Refractory Renal Cell Carcinoma
June 1st 2020"The acceptance of our NDA filing marks yet another important milestone for AVEO, as we pursue our goal of providing RCC patients whose disease has relapsed or become refractory to multiple lines of therapy with a meaningful new treatment option."
FDA Accepts BLA for Pegfilgrastim Biosimilar to Treat Chemotherapy-Induced Infection
May 27th 2020"Pegfilgrastim plays a vital role in oncology care, and this acceptance by FDA is an important step toward giving oncologists and their patients greater access by providing another option to help support the immune system following chemotherapy."
FDA Grants Fast Track Designation to Novel Small Molecule Drug in LPL and WM
May 26th 2020"Fast Track Designation for lymphoplasmacytic lymphoma and Waldenstrom’s macroglobulinemia further supports our clinical development strategy to quickly and efficiently provide these patients with an effective therapeutic alternative."
Sacituzumab Govitecan Brings Long-Awaited Progress in the Treatment Landscape of mTNBC
May 25th 2020In an interview with Targeted Oncology following the announcement of sacituzumab govitecan accelerated FDA approval, Hope Rugo, MD, discussed the published data from the phase 1/2 basket trial and the relevance of having sacituzumab govitecan available for the treatment of patients with metastatic triple negative breast cancer.
Neoadjuvant Atezolizumab With Chemotherapy Feasible in Advanced NSCLC
May 24th 2020"Our trial, together with ongoing randomized trials, provides more evidence on the risks and benefits of immunotherapy as a neoadjuvant treatment, and could help to answer questions regarding the optimal duration, best surrogate endpoint, and best predictive biomarkers for treatment."
Positive Responses With Belumosudil in GVHD Spark Pending FDA Submission
May 21st 2020"These results demonstrate the potential of belumosudil to become a cornerstone of the cGVHD treatment paradigm if approved, as it delivers meaningful and sustained benefits to patients with this serious condition."
FDA Approval Sought for Selinexor in Previously Treated Multiple Myeloma
May 20th 2020"If approved, we believe selinexor could become an important addition to the treatment paradigm for patients with relapsed or refractory multiple myeloma, and we look forward to working with the FDA during the review process."