FDA Approves Radiohybrid PET Diagnostic Agent Posluma for PSMA-Positive Lesions in Prostate CancerMay 30th 2023
The PET diagnostic imaging agent, flotufolastat F 18 injection has been approved by the FDA for the identification of prostate-specific membrane antigen–positive lesions in men with prostate cancer
FDA Approves Oral SERD Elacestrant for ESR1-Mutant ER+, HER2– Metastatic Breast CancerJanuary 27th 2023
The FDA has granted an accelerated approval to elacestrant (Orserdu) for the treatment of patients with estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer following at least 1 prior lines of endocrine therapy.
Tucatinib and Trastuzumab Combination Gains FDA Approval for RAS Wild-Type HER2+ mCRCJanuary 19th 2023
The FDA has granted accelerated approval to tucatinib and trastuzumab for RAS wild-type, HER2-positive metastatic colorectal cancer. The prescribing information includes warnings for diarrhea and hepatotoxicity.
Real-World Patient-Reported Outcomes for Axi-Cel Align With Clinical Trial QOL, Symptomology DataDecember 11th 2022
Real-world data from patient-reported outcomes suggest that axicabtagene ciloleucel is associated with temporary worsening of quality of life with statistically and clinically significant improvements within 1-year postinfusion.
Adjuvant Abemaciclib Plus Endocrine Therapy Sustains Benefit for Patients With HR+/HER2– High-Risk Early Breast CancerDecember 9th 2022
A landmark 4-year analysis of invasive-disease free survival outcomes from the phase 3 monarchE study support the use of adjuvant abemaciclib with endocrine therapy for patients with hormone receptor–positive, HER2-negative, node-positive early breast cancer.
Trastuzumab Deruxtecan Continues to Elicit Encouraging Responses in Patients With Metastatic Gastric/GEJ CancerSeptember 17th 2022
After 10 months of follow-up, the confirmed objective response rate among patients with metastatic gastric cancer or gastroesophageal junction adenocarcinoma who received trastuzumab deruxtecan was 41.8%.
FDA Schedules ODAC Meetings to Review Pending Drug ApplicationsAugust 6th 2022
The FDA has scheduled 3 sessions for the Oncologic Drugs Advisory Committee to review updates on the new drug application for poziotinib tablets and data for the continued approval of indications for melphalan flufenamide and duvelisib.
Early Treatment for Hot-Flashes Is Prognostic of Worse Outcomes for Hormonal Therapy in Patients with ER+ Breast CancerJuly 12th 2022
Patients with breast cancer who experience adjuvant hormone therapy (AHT)-related hot flashes and are treated for hot flashes at the beginning of therapy had worse outcomes than those who did not.
Luspatercept Linked With Maintained Reduction in Transfusion Dependence Among Patients With β-ThalassemiaJune 24th 2022
Updated data from the phase 3 BELIEVE trial revealed a sustained reduction in the need for red blood cell transfusions among patients with β-thalassemia who received treatment with luspatercept-aamt.
Pediatric/Young Adult Patients With B-ALL Continue to Derive Benefit From Tisagenlecluecel at 5-Year Follow-UpJune 22nd 2022
Heavily pretreated pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia maintained response with tisagenlecelucel according to long-term follow-up data from the phase 2 ELIANA trial.