FDA Approves CDx for Lorlatinib in ALK-Positive Non–Small Cell Lung Cancer
March 9th 2021The FDA has granted approval to the VENTANA ALK CDx Assay as a companion diagnostic to identify patients with ALK-positive non–small cell lung cancer who may be eligible for treatment with the recently approved ALK inhibitor lorlatinib.
Doctors Debate: Is Systemic or Liver-Directed Therapy Best for Hepatocellular Carcinoma?
March 5th 2021As part of the virtual 17th Annual Meeting of the International School of Gastrointestinal Oncology, a debate ensued around whether liver-directed or systemic therapy is best for the treatment of patients with HCC.
Blinatumomab Improves Survival Outcomes Over Chemotherapy in High-Risk B-ALL
March 3rd 2021Blinatumomab consolidation demonstrated significantly prolonged event-free survival in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia when compared with chemotherapy before allogeneic hematopoietic stem cell transplantation.
Pembrolizumab Indication for Treatment of Metastatic SCLC Withdrawn
March 2nd 2021Pembrolizumab has been withdrawn from the United States market as a treatment option for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
FDA Receives New Drug Application for Ivosidenib in IDH1+ Cholangiocarcinoma
March 1st 2021A New Drug Application was submitted to the FDA for ivosidenib tablets as a potential treatment option for patients with previously treated IDH1-mutated cholangiocarcinoma. The company is requesting Priority Review be granted to the application.
FDA Approves Melflufen Combination for Triple-Class Refractory Multiple Myeloma
February 27th 2021The FDA has granted approval to melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
Cabozantinib Lands Breakthrough Therapy Designation in RAI-Refractory Differentiated Thyroid Cancer
February 26th 2021The FDA has granted Breakthrough Therapy Designation to cabozantinib for the potential treatment of patients with differentiated thyroid cancer that has progressed following prior therapy and who are radioactive iodine-refractory if eligible for radioactive iodine.
FDA Grants Breakthrough Therapy Designation to Tipifarnib in HRAS+ HNSCC
February 25th 2021The FDA has granted a Breakthrough Therapy Designation to tipifarnib for the treatment of patients with recurrent or metastatic HRAS-mutant head and neck squamous cell carcinoma with variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy.
Promising 5-Year Outcomes Shown With CAR T-Cell Therapy in R/R B-Cell Lymphoma
February 24th 2021For the treatment of relapsed or refractory aggressive B-cell lymphomas, chimeric antigen receptor–modified T-cell therapy is becoming more widely used. Still, little is known about outcomes for patients who receive CAR-modified T-cell therapy beyond 2 years.
FDA Grants Priority Review to Ruxolitinib in Steroid-Refractory cGVHD
February 23rd 2021The FDA has accepted a supplemental New Drug Application for ruxolitinib and granted it Priority Review as a potential treatment option for adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease.
Study of Betalutin in R/R Follicular Lymphoma Shows Good Progress Despite COVID-19
February 22nd 2021Enrollment of patients with relapsed or refractory follicular lymphoma in a phase 2 LYMRIT 37-01 PARADIGME study of third-line Lu lilotomab satetraxetan has increased accrual to 2-5 patients per month.
FDA Approves Cemiplimab in Frontline PD-L1-High Advanced NSCLC
February 22nd 2021The FDA has granted approval to cemiplimab-rwlc, for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression, as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK, or ROS1 aberrations.
Adjuvant Imatinib Confirmed Beneficial for RFS in High-Risk Gastrointestinal Stromal Tumors
February 20th 2021Adjuvant imatinib has demonstrated significant improvement in relapse-free survival over a 2-year period and a mild trend toward long-term improvement in failure-free survival as treatment of patients with high-risk gastrointestinal stromal tumors, according to 9.1-year follow-up results from a randomized phase 3 study.
FDA-Approved Advanced GIST Therapy Can Elicit Durable Responses With Tolerable Safety
February 20th 2021In patients with gastrointestinal stromal tumors who have received 3 or more prior therapies, there remain unmet needs to overcome resistance to the standard-of-care, imatinib, a tyrosine kinase inhibitor, and prolong the 6.3-month+ progression-free survival achieved with the FDA-approved TKI ripretinib.
Precision Medicine Shapes the Future of Follicular Lymphoma Management
February 19th 2021In an interview with Targeted Oncology, Carla Casulo, MD, discussed the modern management of patients with relapsed/refractory follicular lymphoma. She also explained how ongoing research may shape the future of the field.
Addition of Daratumumab to Rd/Vd Heightens MRD Negativity Rates in R/R Myeloma
February 18th 2021High rates of sustained MRD negativity were achieved with daratumumab-containing combinations compared with the standard-of-care combinations, according to an exploratory analysis of 2 ongoing clinical trials.
Developers Submit BLAs for Enfortumab Vedotin for 2 Urothelial Carcinoma Indications
February 18th 2021The submission of 2 Biologic License Applications for enfortumab vedotin-ejfv have been made to the FDA for consideration as treatment of patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and who are ineligible for cisplatin.
FDA Grants Priority Review to Vicineum for High-Risk, BCG-Unresponsive NMIBC
February 17th 2021The FDA has accepted a Biologic License Application for Vicineum as a treatment option for patients with high-risk, Bacillus Calmette-Guerin-unresponsive non–muscle invasive bladder cancer, and granted it Priority Review,.
Nivolumab Plus Ipilimumab Improves Survival, Shows Activity in Sarcomatoid RCC
February 17th 2021The immunotherapy combination of nivolumab and ipilimumab has improved survival and response rates compared with sunitinib, in patients with advanced renal cell carcinoma with sarcomatoid histology, including those with intermediate and poor-risk features.