A scheduled meeting of the FDA's Oncologic Drugs Advisory Committee supported the indication of pexidartinib as a treatment for adult patients with symptomatic tenosynovial giant cell tumor. The panel voted 12 to 3 in favor of the CSF1R inhibitor.
Pomalidomide was granted a breakthrough designation by the FDA for use as treatment for both patients with HIV-positive Kaposi sarcoma who have had prior chemotherapy and patients with HIV-negative Kaposi sarcoma.
Ramucirumab monotherapy has received an approval from the FDA for the treatment of patients with hepatocellular carcinoma who have an alpha fetoprotein of ≥400 ng/mL and have been previously treated with sorafenib.
In topline findings from the phase II DESTINY-BreastO1 study, [fam-] trastuzumab deruxtecan demonstrated encouraging responses in patients with unresectable and/or metastatic HER2-positive breast cancer that has been previously treated with ado-trastuzumab emtansine.
The phase III ASCEND trial has met its primary endpoint, as findings from the study showed that patients with previously treated chronic lymphocytic leukemia had a statistically significant and clinically meaningful improvement in PFS with acalabrutinib compared with the combination of rituximab and either idelalisib or bendamustine.
Mirvetuximab soravtansine, an antibody-drug conjugate, led to a favorable benefit-risk profile in patients with folate receptor alpha–positive ovarian cancer according to a comprehensive analysis of the phase III FORWARD trial.
A phase III clinical trial evaluating cabozantinib (Cabometyx) in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) in patients with previously untreated advanced renal cell carcinoma has been initiated, according to Exelixis, the developer of cabozantinib.
Ado-trastuzumab emtansine has been approved by the FDA for use as an adjuvant treatment option for patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab and chemotherapy.
Single-agent ivosidenib (Tibsovo) has received FDA approval for the first-line treatment of adult patients with <em>IDH1</em>-mutant acute myeloid leukemia, as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy.
Combining lenalidomide with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone did not improve progression-free survival compared with placebo and R-CHOP as a frontline therapy in patients with activated B-cell-type diffuse large B-cell lymphoma, missing the primary endpoint of the phase III ROBUST trial.
The PDGFRα antagonist olaratumab (Lartruvo) will be withdrawn from the market for the treatment of patients with advanced soft tissue sarcoma due to disappointing findings in the phase III ANNOUNCE trial, according to Eli Lilly and Company.
Apalutamide has been submitted for FDA approval for the treatment of patients with metastatic castration-sensitive prostate cancer.
A new VENTANA HER2 dual in situ hybridization companion diagnostic assay has been launched by Roche to help identify <em>HER2</em> amplification for patients with breast cancer and gastric cancer who could be eligible to receive trastuzumab.
A new drug application seeking the approval of darolutamide as a treatment for patients with nonmetastatic castration-resistant prostate cancer has been granted a priority review designation by the FDA.
Treatment with tagraxofusp led to a high rate of responses in patients with blastic plasmacytoid dendritic cell neoplasm regardless of whether patients had received prior treatment or not, findings from a nonrandomized phase II trial demonstrated.
A new drug application seeking the approval of pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor will be discussed by the Oncologic Drugs Advisory Committee during a meeting on May 14, 2019, the FDA has announced.
Pembrolizumab (Keytruda) has received approval from the FDA in combination with axitinib (Inlyta) for the frontline treatment of patients with advanced renal cell carcinoma, based on phase III findings from the KEYNOTE-426 trial.
The approval of the PD-L1 22C3 pharmDX assay has been expanded by the FDA to be used as a companion diagnostic for identifying more patients with stage III or metastatic non–small cell lung cancer who can undergo frontline treatment with pembrolizumab.
The approval for pembrolizumab (Keytruda) has been expanded to include the frontline treatment of patients with stage III non–small cell lung cancer, who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 expression level of ≥1% and do not harbor <em>EGFR</em> or <em>ALK</em> aberrations.
Leo I. Gordon, MD, discusses recent updates in Hodgkin lymphoma and NHL and pointed to research on the horizon.
Combining osimertinib with the MET inhibitor savolitinib demonstrated encouraging antitumor activity and an acceptable safety profile in patients with <em>EGFR</em>-mutant, <em>MET</em>-amplified non–small cell lung cancer who previously received EGFR TKIs, suggesting the regimen could be successful in overcoming <em>MET</em>-driven resistance.
Based on findings from 2 phase III studies, a supplemental biologics license application has been submitted to the FDA seeking the approval of luspatercept for the treatment of adult patients with anemias.
Overall survival was significantly improved in patients with relapsed/refractory <em>FLT3</em> mutation–positive acute myeloid leukemia who were treated with the FLT3 inhibitor gilteritinib, according to updated findings presented during the 2019 AACR Annual Meeting.
In phase I findings presented during the 2019 AACR Annual Meeting, HER2-directed CAR T-cell therapy and lymphodepletion chemotherapy was found to be safe and effective as a treatment for pediatric and adult patients with advanced HER2-positive sarcoma.
The phase III JAVELIN Ovarian PARP 100 study has been discontinued, according to Merck KGaA and Pfizer, the companies that collaborated on the trial.<sup> </sup>The ongoing trial was investigating the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance avelumab in combination with talazoparib in patients with locally advanced or metastatic ovarian cancer.
The FDA has approved the combination of atezolizumab plus carboplatin and etoposide as a first-line treatment for patients with extensive-stage small cell lung cancer.
The biologics license application for eflapegrastim was voluntarily withdrawn by Spectrum Pharmaceuticals as the company requires more time to complete additional manufacturing-related information requested by the FDA.
A rolling submission has been completed to the FDA for the potential approval of the combination of daratumumab (Darzalex) plus lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Nab-paclitaxel plus gemcitabine in the adjuvant setting did not improve disease-free survival in patients with pancreatic cancer compared to gemcitabine alone, according to topline results from the phase III APACT trial that have been confirmed by independent radiological review.
Progression-free survival, the primary endpoint of the RELAY trial, was significantly improved with frontline ramucirumab in combination with erlotinib compared to placebo plus erlotinib in patients with metastatic <em>EGFR</em>-mutant non–small cell lung cancer.