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Duvelisib Granted Priority Review by FDA for CLL and Follicular Lymphoma
April 9th 2018A new drug application seeking a full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma has been granted a priority review by the FDA.
Short Course of CAPOX as Effective as 6-Month Treatment for Advanced Colon Cancer
April 9th 2018Three months of capecitabine (Xeloda) and oxaliplatin (CAPOX) was noninferior for recurrence of death compared with a 6-month course, according to the published findings from IDEA, a pooled analysis of 6 phase III trials.
Maintenance Rucaparib Approved by FDA for Ovarian Cancer
April 6th 2018Based on findings from the phase III ARIEL3 trial, rucaparib (Rubraca) tablets have been approved by the FDA for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, according to Clovis Oncology, the manufacturer of the PARP inhibitor.
Pembrolizumab Combo Fails to Improve PFS in Melanoma
April 6th 2018According to findings from the phase III ECHO-301/KEYNOTE-252 trial, progression-free survival was not improved with the combination of the PD-1 inhibitor pembrolizumab (Keytruda) and the IDO1 inhibitor epacadostat versus single-agent pembrolizumab in patients with unresectable or metastatic melanoma.
Sanjeevani Arora Receives Cancer Research Grant from Department of Defense
April 6th 2018The US Department of Defense has selected Sanjeevani Arora, PhD, as the recipient of the Peer Reviewed Cancer Research Program Career Development award and grant for fiscal year 2017. The grant will be used to fund clinical efforts benefiting both military and civilian patients.
Novel Radiolabeled ADC Being Explored for Older Patients with AML
April 6th 2018Studies have shown that older patients with either active, relapsed, or refractory acute myeloid leukemia have had lower survival rates, poor risk assessments, and limited therapeutic options. The standard care of these patients is salvage chemotherapy. Investigators are pretreating patients in this high-risk population with Iomab-B, a novel radiolabeled antibody–drug conjugate as part of a stem cell transplantation regimen in hopes of improving remission and survival outcomes.
Response Rate Tops 90% With Larotrectinib in TRK+ Pediatric Cancers
April 5th 2018According to findings from a phase I/II study published in <em>The Lancet Oncology</em>, there was an “unprecedented” objective response rate of 93% with larotrectinib in patients with TRK fusion–positive solid tumors.
Expert Highlights Potential of Targeted Therapies in Combinations for CLL
April 5th 2018The treatment paradigm of chronic lymphocytic leukemia continues to advance, with many ongoing clinical trials investigating combinations seeking to build upon the success seen with Bruton’s tyrosine kinase inhibitors. Such potential combination therapies for CLL include venetoclax (Venclexta) with either ibrutinib (Imbruvica) or acalabrutinib (Calquence).
Rova-T Delivers Disappointing Results in Phase II SCLC Trial
April 5th 2018In preliminary findings from the single-arm, phase II TRINITY trial investigating Rovalpituzumab Tesirine (Rova-T) in the third-line setting for patients with relapsed/refractory small cell lung cancer (SCLC) demonstrating high DLL3 expression, the DLL3-targeted antobody-drug conjugate delivered disappointing results.
Priority Review Granted by FDA to Dacomitinib for Frontline Treatment in NSCLC
April 5th 2018According to Pfizer, manufacturer of a pan-human EGFR tyrosine kinase inhibitor (TKI), a priority review has been granted by the FDA for their TKI inhibitor, dacomitinib, in the frontline setting for patients with <em>EGFR</em>-positive locally advanced or metastatic non–small cell lung cancer.
Nivolumab Demonstrates Durable Responses in Hodgkin Lymphoma, Follow-Up Data Shows
April 4th 2018According to results from an extended follow-up of the CheckMate-205 trial looking at patients with relapsed/refractory classical Hodgkin lymphoma after autologous hematopoietic cell transplantation, nivolumab (Opdivo) caused an overall objective response rate of 69%.
MRD Associated With Worse Outcomes in AML
April 4th 2018According to results published in <em>The New England Journal of Medicine</em>, molecular minimal residual disease was associated with a higher rate of relapse and a lower rate of relapse-free survival and overall survival for patients with newly-diagnosed acute myeloid leukemia.
Moxetumomab Pasudotox Granted FDA's Priority Review Designation for Hairy Cell Leukemia
April 4th 2018Moxetumomab pasudotox has been granted a priority review by the FDA for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least 2 prior lines of therapy, according to AstraZeneca (MedImmune), the developer of the anti-CD22 recombinant immunotoxin.
A Look Back at FDA News in the Month of March
April 3rd 2018Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018.
Olaparib Under Review by EMA for BRCA-mutated, HER2-negative Breast Cancer
April 3rd 2018A marketing authorization application for olaparib (Lynparza) for the treatment of women with <em>BRCA</em>-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting has been accepted by the European Medicines Agency.
Kris on the Success of Durvalumab as a Major Advancement in NSCLC
April 3rd 2018In an interview with <em>Targeted Oncology</em>, Kris, a medical oncologist and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center, discussed how the approval of durvalumab has changed the treatment landscape of NSCLC.
Denosumab Granted European Approval for Myeloma
April 3rd 2018Based on data from the phase III 482 study, denosumab (Xgeva) has been approved for an expanded indication by the European Commission for the prevention of skeletal-related events in adult patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.
Fabrice Barlesi Selected to Receive the Heine H. Hansen Award by ESMO and IASLC
March 30th 2018The European Society for Medical Oncology in conjunction with the International Association for the Study of Lung Cancer has selected Fabrice Barlesi, MD, PhD, to receive the 2018 Heine H. Hansen Award. Barlesi will be presented with the award at the 2018 European Lung Cancer Congress, which will be held April 11-14 in Geneva, Switzerland.
Expert Discusses Promise of Novel Sarcoma Vaccine and Other Ongoing Research in the Field
March 30th 2018In an interview with <em>Targeted Oncology</em>, Pollack, assistant member, Clinical Research Division, assistant professor, Division of Oncology, University of Washington, and attending physician at Seattle Cancer Care Alliance, discussed some of the advancements his lab is making in the field of sarcoma.
Trastuzumab Biosimilar Receives Positive Opinion From CHMP for European Approval
March 29th 2018A marketing authorization for ABP 980, a biosimilar to trastuzumab (Herceptin), has been issued a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
T-VEC Injections Safe in Patients with Advanced-Stage Liver Metastases
March 29th 2018According to early results of an ongoing early-phase study presented at the 2018 Society of Interventional Radiology Annual Scientific Meeting, image-guided injections of talimogene laherparepvec immunotherapy (T-VEC, Imylgic) were deemed tolerable in patients with advanced-stage liver metastases.
Promise Seen With Frontline Pembrolizumab Plus Chemotherapy in Ovarian Cancer
March 28th 2018The combination of first-line platinum-containing chemotherapy plus the anti-PD-1 agent pembrolizumab (Keytruda), followed by pembrolizumab maintenance therapy, was safe and tolerable in patients with advanced ovarian cancer, according to preliminary data from a small clinical trial presented at the 2018 Society of Gynecologic Oncology Annual Meeting.
Trials Consider Role of Immunotherapy in Breast Cancer
March 28th 2018Mixed results have occured in recent trials testing immuotherapy in patients with breast cancer. Checkpoint inhibitors have been used as monotherapy in a pair of trials, reporting lackluster overall response rates. When immunotherapy was paired with chemotherapy, on the other hand, it usually showed better results, and gave signals that immunotherapies combined with targeted agents could work better than immunotherapy alone.
Priority Review Granted by FDA for Nivolumab Plus Ipilimumab Combo for MSI-H/dMMR CRC
March 28th 2018There has been a supplemental biologics license application (sBLA) granted priority review by the FDA for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases of metastatic colorectal cancer (mCRC) following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.