Managing Risk of COVID-19 in Geriatric Patients With Cancer
April 26th 2020In an interview with Targeted Oncology, William Dale, MD, discussed his experience with caring for geriatric oncology patients during the COVID-19 pandemic. He also shared best practices for using telemedicine during this time.
Dostarlimab on the Road to Progress in dMMR Endometrial Cancer
April 24th 2020“There are limited treatment options for women with advanced or recurrent endometrial cancer, and prognosis of these patients is poor. The results observed in the GARNET trial indicate the potential of dostarlimab to offer a new treatment option for women with this challenging disease.”
Novel Monoclonal Antibody Demonstrates Clinical Activity in Gynecologic Malignancies
April 23rd 2020"We are seeing clinically meaningful monotherapy activity of DKN-01 in heavily pre-treated endometrial cancer and carcinosarcoma populations, including a complete response, a partial response, and durable tumor reductions in many patients. In combination with paclitaxel, DKN-01 is generating durable responses and disease control in paclitaxel-experienced patients."
Pembrolizumab sBLA Resubmitted to FDA With New Dosing Frequency
April 23rd 2020"The oncology community is rapidly adapting cancer care during the COVID-19 pandemic in order to minimize exposure and keep cancer patients as safe as possible. Now more than ever, we believe it is critical to pursue a six-week dosing schedule for Keytruda."
FDA Grants Accelerated Approval to Sacituzumab Govitecan in mTNBC
April 22nd 2020"The approval of sacituzumab govitecan, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease."
FDA Grants RMAT Designation to Tisagenlecleucel in R/R Follicular Lymphoma
April 22nd 2020“This designation supports the advancement of Kymriah, which could potentially address an unmet need in certain patients with follicular lymphoma, as we strive to reimagine medicine at Novartis. These patients are often faced with the burden of several years of various treatments as their disease continues to progress.”
FDA Approves cobas HPV Test for Measurement of Cervical Cancer Risk in Women with High-Risk HPV
April 21st 2020"The approval of our HPV test for the cobas 6800 and 8800 Systems enables molecular laboratories to achieve the efficiency and scale they need to meet the demands of high-volume cervical screening programs..."
CheckMate-9ER Hits Efficacy Targets in Frontline Advanced RCC
April 20th 2020“The results from the pivotal CheckMate-9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients.”
FDA Grants Two Fast Track Designations to Surufatinib in Pancreatic and Extrapancreatic NETs
April 17th 2020The FDA granted two Fast Track designations to surufatinib for the treatment of both advanced and progressive pancreatic neuroendocrine tumors and extra-pancreatic NETs in patients who are not amenable for surgery, according to a press release from the developer, Chi-Med. The agent was previously granted Orphan Drug Designation by the FDA for this indication.
Liquid Biopsy Accurately Detects Early-Stage Pancreatic Ductal Adenocarcinoma
April 17th 2020A liquid biopsy test with the ability to screen for a panel of biomarkers rather than just one can reportedly detect pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, in the early stages of disease.
FDA Approves Tucatinib Plus Trastuzumab/Capecitabine in HER2-Positive Breast Cancer
April 17th 2020The FDA granted accelerated approval for tucatinib tablets in combination with trastuzumab and capecitabine as treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases who have received one or more prior anti-HER2-based regimens in the metastatic setting. The approval comes 4 months ahead of the targeted action date from the FDA’s Real-Time Oncology Review.
Niraparib Grabs Regulatory Attention in China for Treatment of Advanced Ovarian Cancer
April 16th 2020Niraparib was granted Priority Review in China as a 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, by the National Medical Products Administration.
FDA Approves Novel Diagnostic Assay to Accompany Encorafenib in Treatment of mCRC
April 16th 2020The FDA has granted approval to the therascreen BRAF V600E Kit as a companion diagnostic to encorafenib, a BRAF inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer harboring a BRAF V600E mutation, as detected by an FDA approved test, in combination with cetuximab after prior therapy.<br />
Telemedicine Takes the Lead in Cancer Care Strategy During the COVID-19 Outbreak
April 16th 2020In an interview with Targeted Oncology, H. Jack West, discussed the role telemedicine has taken to support the treatment and post-treatment surveillance of patients with cancer during the COVID-19 pandemic.
Pembrolizumab Deemed Active Treatment for Brain Metastasis in NSCLC
April 15th 2020Brain metastasis responses were elicited from treatment with pembrolizumab in patients with non–small cell lung cancer, in a PD-L1–positive cohort of a phase II clinical trial conducted by researchers at Yale Cancer Center. According to a YCC press release, pembrolizumab prolonged overall survival with limited toxicity in these patients.
R-BAC Can Potentially Bridge Later-line Therapy in R/R Mantle Cell Lymphoma
April 15th 2020A high response rate was demonstrated with the rituximab, bendamustine, and cytarabine regimen as treatment of patients with relapsed or refractory mantle cell lymphoma following treatment with a Bruton tyrosine kinase inhibitor, hinting that the regimen may be an effective bridge to allogeneic stem cell transplantation in patients who are transplant eligible, according to data from a retrospective cohort study.
Frontline Tislelizumab Combination Significantly Improves PFS in Nonsquamous NSCLC
April 14th 2020The combination of tislelizumab, a PD-L1 antibody, pemetrexed and platinum-based chemotherapy achieved a statistically significant prolongation in progression-free survival compared with pemetrexed and platinum chemotherapy alone as first-line treatment of patients with nonsquamous non–small cell lung cancer, meeting the primary end point of a phase III BGB-A317-304 trial.
Physicians Successfully Treat Severe COVID-19 in Patient With Multiple Myeloma
April 11th 2020In the epicenter of the coronavirus disease 2019—Wuhan, China—a 60-year-old patient with multiple myeloma presented with chest tightness with no fever or cough, in early February. The patient was successfully treated with the anti–interleukin-6 receptor antibody tocilizumab, according to a case study published in Blood Advances.
Prognostic Tool Predicts Length of Watch and Wait Period in CLL
April 10th 2020The appropriate gap between diagnosis of chronic lymphocytic leukemia and treatment is now clearer as a new prognostic tool, IPS-E, that can predict the length of “watch and wait” has been introduced, according to a press release from the American Society of Hematology.
Avelumab Granted FDA Breakthrough Therapy Designation in Metastatic Urothelial Cancer
April 9th 2020A Biologics License Application for avelumab, a PD-L1 inhibitor, was submitted to the FDA for consideration as first-line treatment of patients with locally advanced or metastatic urothelial cancer and the agent was granted Breakthrough Therapy Designation, announced Merck KGaA, in a press release.<br />
FDA Approves Encorafenib Plus Cetuximab in BRAF V600E+ mCRC
April 9th 2020The FDA has approved the combination of encorafenib and cetuximab as treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy, according to a press release from Pfizer.
Icotinib Comparable to Gefitinib for Brain Metastasis of EGFR-Mutated NSCLC
April 8th 2020Icotinib, an EGFR tyrosine kinase inhibitor, demonstrated similar efficacy to gefitinib as a treatment of brain metastasis in patients with EGFR-mutated non–small cell lung cancer, results from a Chinese retrospective study showed.
FDA Grants Priority Review to BLA for First-Line Nivolumab/Ipilimumab Plus Limited Chemo in NSCLC
April 8th 2020The FDA has accepted the Biologics License Application for and granted Priority Review to the combination of nivolumab plus ipilimumab with limited chemotherapy as a first-line treatment of patients with metastatic or recurrent non–small cell lung cancer who have no EGFR or ALK genomic tumor aberrations, according to a press release from Bristol Myers Squibb. The Prescription Drug Free User Act target action date is set as August 6, 2020, and the combination was granted Fast Track designation.