May 5th 2020
Cemiplimab induced clinically meaningful and durable responses in patients with advanced basal cell carcinoma.
The combination of nivolumab and regorafenib demonstrated promising antitumor activity in patients with gastric and colorectal cancer.
May 4th 2020
The FDA has granted an orphan drug designation to HQP1351 for the treatment of patients with chronic myeloid leukemia.
Transformative clinical trials of PARP inhibitors have revolutionized the frontline treatment paradigm in advanced ovarian cancer.
May 1st 2020
The FDA has approved a new subcutaneous formulation of daratumumab for the treatment of patients with multiple myeloma.
A European panel has recommended approval of encorafenib in combination with cetuximab for the treatment of adult patients with BRAF V600E–mutant metastatic colorectal cancer.
The FDA has granted a priority review designation to CC-486 for the maintenance treatment of adult patients with acute myeloid leukemia.
A European panel has recommended approval of luspatercept for the treatment of anemia in patients with myelodysplastic syndromes and beta thalassemia.
A European panel has recommended approval of a subcutaneous formulation of daratumumab for the treatment of patients with multiple myeloma.
April 30th 2020
Updated data from the pivotal phase 3 FLASH trial showed that SGX301 (synthetic hypericin) continued to demonstrate strong clinical activity in patients with cutaneous T-cell lymphoma.
April 29th 2020
The FDA has approved niraparib for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy.
Findings from the pivotal phase 3 PROfound trial of olaparib as a treatment for men with metastatic castration-resistant prostate cancer harboring homologous recombination repair (HRR) gene alterations were published in the New England Journal of Medicine.
Paolo A. Ascierto, MD, discussed lessons he has learned from the COVID-19 crisis both in the melanoma treatment paradigm and in the broader immuno-oncology spectrum.
The FDA has approved an updated dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg across all indications in adult patients.
April 28th 2020
Avapritinib did not improve progression-free survival versus regorafenib in previously treated patients with locally advanced unresectable or metastatic gastrointestinal stromal tumor, missing the primary end point of the phase 3 VOYAGER trial.
A new drug application has been submitted in Japan seeking approval of a subcutaneous formulation of daratumumab.
Pacritinib is being explored in the phase 3 PRE-VENT trial as a treatment for cytokine storm in hospitalized patients with severe COVID-19.
April 27th 2020
Continuous dosing with dabrafenib and trametinib improved progression-free survival compared with intermittent dosing in patients with BRAF mutation–positive advanced melanoma.
Mobocertinib (TAK-788) has received an FDA breakthrough therapy designation for the treatment of patients with EGFR exon 20-mutant non–small cell lung cancer.
The PD-1 inhibitor cemiplimab significantly improved overall survival as a frontline treatment for patients with high–PD-L1 non–small cell lung cancer.