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Gina Columbus

Articles

Sintilimab/Pemetrexed Regimen Significantly Improves PFS in Advanced NSCLC

August 08, 2020

Sintilimab injection plus pemetrexed and platinum-based therapy led to a statistically significant improvement in progression-free survival compared with chemotherapy alone as a first-line treatment for patients with locally advanced or metastatic nonsquamous non–small cell lung cancer.

FDA Grants Adjuvant Osimertinib Breakthrough Status in Early-Stage EGFR+ NSCLC

July 30, 2020

The FDA has granted a breakthrough therapy designation to osimertinib for the adjuvant treatment of patients with stage IB, II, and IIIA EGFR-mutated non–small cell lung cancer following complete resection with curative intent.

Pembrolizumab Approved in China for Second-Line PD-L1+ Esophageal Cancer

June 22, 2020

The National Medical Products Administration in China has approved pembrolizumab for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 as determined by an approved test, following disease progression on 1 prior line of systemic therapy.

Zanubrutinib Gains Approval in China for Relapsed/Refractory CLL/SLL and MCL

June 03, 2020

China's National Medical Products Administration has approved zanubrutinib (Brukinsa) for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma who have received at least 1 prior therapy, as well as for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.

FDA Places Partial Hold on Non-Hodgkin Lymphoma Trial

March 11, 2020

The FDA has placed a partial clinical hold on a phase I trial assessing the autologous T-cell therapy ACTR707 in combination with rituximab for patients with CD20-positive, B-cell non-Hodgkin lymphoma due to a safety concern.

FDA Grants Breakthrough Designation to JNJ-6372 for EGFR Exon 20-Mutant NSCLC

March 11, 2020

The FDA has granted a breakthrough therapy designation to JNJ-61186372 for the treatment of patients with EGFR-positive metastatic non–small cell lung cancer who harbor exon 20 insertion mutations, and whose disease has progressed on or after platinum-based chemotherapy.

Ixazomib Frontline Triplet Misses PFS Endpoint in Transplant-Ineligible Myeloma

March 10, 2020

The triplet therapy of ixazomib, lenalidomide, and dexamethasone showed an improvement in progression-free survival, but it was not statistically significant, compared with lenalidomide/dexamethasone alone for patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplant.

FDA Grants Breakthrough Designation to Debio 1143 in Frontline Head and Neck Cancer

February 27, 2020

The FDA has granted a breakthrough therapy designation to Debio 1143, an inhibitor of apoptosis protein antagonist, for the treatment of patients with previously untreated, unresectable, locally advanced squamous cell carcinoma of the head and neck in combination with standard cisplatin-based concomitant fractionation chemoradiation therapy