Lisa Astor is the Associate Editorial Director for Targeted Oncology. Astor received her Bachelor of Arts in English Literature from New York University.
Mobocertinib was granted a Breakthrough Therapy designation by the FDA for the treatment of patients with metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
"Our team has done an excellent job continuing to advance our clinical programs, operations and business objectives during the COVID-19 pandemic. March was one of the higher enrolling months in the SIERRA trial with multiple patients enrolled after the COVID-19 pandemic emerged in full force with active screening continuing."
"Adavosertib demonstrated promising preliminary clinical activity in patients with unselected uterine serous cancer."
“These topline results from the CheckMate 743 trial demonstrate the potential of Opdivo plus Yervoy in previously untreated patients with malignant pleural mesothelioma, and is another example of the established efficacy and safety of the dual immunotherapy combination seen in multiple tumor types.”
In response to the coronavirus disease 2019 pandemic, the American Oncology Network has launched telehealth services across all of its sites. The use of telehealth technology will allow for patients to continue to receive convenient access to care and still help mitigate the spread of COVID-19.
The FDA has approved pemigatinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.
Treatment with olaparib demonstrated similar outcomes to standard-of-care chemotherapy treatment in patients with BRCA wild-type, platinum-sensitive, recurrent epithelial ovarian cancer in the phase II CLIO study. As such, olaparib failed to demonstrate a significant improvement in survival over chemotherapy.
The FDA has granted approval to mitomycin gel as treatment of adult patients with low grade upper track urothelial cancer.
The CALAVI clinical trial is being initiated to explore the potential of acalabrutinib to treat exaggerated immune response, or cytokine storm, in patients who are severely ill with coronavirus disease 2019, according to a press release from the developer, AstraZeneca.
The FDA has approved selumetinib for the treatment of pediatric patients, aged 2 years and above, with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.
The longest follow-up for ibrutinib monotherapy to date maintained the benefit of the Bruton’s tyrosine kinase inhibitor for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma across settings.<br />
The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.
Pembrolizumab demonstrated an improvement in progression-free survival in the first-line treatment of patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer, meeting one of the primary end points of the phase III KEYNOTE-177 trial.
Pembrolizumab demonstrated positive activity in patients with previously treated advanced anal squamous cell carcinoma, regardless of PD-L1 expression, according to the results of the KEYNOTE-158 trial presented at the 2020 Gastrointestinal Cancers Symposium.
A phase III trial is being planned to explore the use of ruxolitinib (Jakafi) to treat patients with coronavirus disease 2019–related cytokine storm, according to a press release from Incyte regarding discussions with the FDA.
A Biologics License Application has been submitted to the FDA for the potential approval of naxitamab for the treatment of patients with relapsed or refractory high-risk neuroblastoma.
The FDA has granted a priority review to a Biologics License Application for remestemcel-L, an allogeneic cell therapy for the treatment of children with steroid-refractory acute graft-versus-host disease, according to a press release from Mesoblast Limited.
A phase II trial of ficlatuzumab, an investigational HGF inhibitory antibody, in patients with relapsed and refractory acute myeloid leukemia joins the growing list of clinical trials halted due to the coronavirus disease 2019 pandemic.
The FDA has approved durvalumab in combination with standard-of-care chemotherapy as a frontline treatment for adult patients with extensive-stage small cell lung cancer.
The FDA has granted a fast track designation a combination of novel selective PI3K-gamma inhibitor IPI-549 plus nivolumab for the treatment of patients with advanced urothelial cancer, according to a press release from developer Infinity Pharmaceuticals.
The FDA has approved a new 420-mg multi-dose vial of Ontruzant a biosimilar of trastuzumab, according to a press release from Samsung Bioepis.
Oncology Venture has met with the FDA to discuss a potential path forward for the approval of dovitinib as a treatment for patients with renal cell carcinoma, according to a press release from the company.
Treatment with SGX301 led to statistically significant responses in patients with cutaneous T-cell lymphoma, according to preliminary top-line results from the pivotal phase III FLASH trial released by Soligenix.
The FDA has issued a guidance regarding clinical trials during the Coronavirus disease 2019 pandemic in recognition of the challenges that may impact standard clinical trial procedures. The guidance acts as a set of recommendations to maintain the safety of patients enrolled onto trials and the trial’s integrity.
A report from the Canadian Myeloproliferative Neoplasm Group has outlined different patterns of treatment failure from JAK inhibitor therapy in patients with myelofibrosis. The report, published in JCO Oncology Practice, suggests management practices for each pattern of response.
The FDA has granted 2 orphan drug designations to ALPN-101 for both the prevention and treatment of acute graft-versus-host disease, according to a press release from Alpine Immune Sciences.
The addition of cediranib to olaparib did not result in improved progression-free survival in comparison with platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer, which was the primary end point of the phase III NRG-GY004 trial, according to a press release from AstraZeneca and Merck.
Cirmtuzumab in combination with ibrutinib induced a clinical benefit rate of 100% in a small cohort of patients with relapsed or refractory mantle cell lymphoma, according to interim results of the phase I/II CIRLL trial.
Progression-free survival failed to meet the threshold for statistical significance with the addition of ixazomib to lenalidomide and dexamethasone in patients with newly diagnosed, transplant-ineligible multiple myeloma in the phase III TOURMALINE-MM2 trial, not meeting the primary endpoint.
The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.