Jason M. Broderick

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.

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.

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.

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.

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.

The PD-1 inhibitor dostarlimab demonstrated clinically meaningful activity in patients with mismatch repair–deficient endometrial cancer.

The National Medical Products Administration of China has accepted an application for the PD-1 inhibitor sintilimab injection for use in combination with pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with nonsquamous non–small cell lung cancer.

Olaparib improved overall survival in previously treated patients with metastatic castration-resistant prostate cancer harboring homologous recombination repair gene mutations.

The China National Medical Products Administration has accepted a new drug application for avapritinib for 2 indications in gastrointestinal stromal tumors.

Global access to neratinib has increased with the drug now being made commercially available in Singapore.

Supplemental biologics license applications have been resubmitted to the FDA for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions across multiple indications.

The REACH2 ruxolitinib acute graft-versus-host disease data have been published in the New England Journal of Medicine.

The United Kingdom’s National Institute for Health and Care Excellence has recommended larotrectinib for the treatment of adult and pediatric patients with advanced NTRK fusion–positive solid tumors.

The FDA has granted an accelerated approval to the antibody-drug conjugate sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with metastatic triple-negative breast cancer.

The FDA has granted a Regenerative Medicine Advanced Therapy designation to tisagenlecleucel for the treatment of patients with relapsed/refractory follicular lymphoma.

The China National Medical Products Administration has accepted a supplemental new drug application for the PD-1 inhibitor tislelizumab for use in combination with chemotherapy for the first-line treatment of patients with advanced squamous non–small cell lung cancer.

The cobas HPV test for cervical cancer screening is now FDA-approved for use on the high-throughput cobas 6800/8800 Systems.

A New Drug Application has been submitted to the FDA for single-agent relugolix for use as a treatment for men with advanced prostate cancer.

The FDA has approved FoundationOne CDx as the registrational companion diagnostic for pemigatinib, which the agency recently approved for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic FGFR2+ cholangiocarcinoma.

COVID-19 trials exploring the oncology treatments ruxolitinib and selinexor have officially begun patient enrollment.

Nivolumab combined with ipilimumab significantly improved overall survival versus chemotherapy in previously untreated patients with malignant pleural mesothelioma.

Nivolumab combined with cabozantinib improved overall survival and progression-free survival compared with sunitinib in patients with previously untreated advanced renal cell carcinoma.