Gina Mauro

Articles

Zanubrutinib Shows Noninferiority, Improved Safety Vs Ibrutinib in Relapsed/Refractory CLL

April 28th 2021

Zanubrutinib demonstrated noninferiority in objective response rates and a trend toward improved progression-free survival when compared with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia.

FDA Grants Priority Review to Mobocertinib for Advanced EGFR Exon 20–Mutant NSCLC

April 28th 2021

The FDA has granted a priority review designation to a new drug application for mobocertinib for the treatment of adult patients with EGFR exon 20 insertion mutation–positive metastatic non–small cell lung cancer, as detected via an FDA-approved assay, who have received previous platinum-based chemotherapy.

FDA Grants Orphan Drug Status to ITIL-168 for Melanoma

April 27th 2021

The FDA has granted an Orphan Drug designation to the investigational tumor-infiltrating lymphocyte therapy ITIL-168 for the treatment of patients with stage IIB to IV melanoma.

EU Panel Recommends Adjuvant Osimertinib in Early-Stage EGFR+ NSCLC

April 26th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended osimertinib for the adjuvant treatment of adult patients with stage IB, II, or IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.

EMA Validates Type II Variation Marketing Authorization Application for Selinexor Triplet in Multiple Myeloma

April 26th 2021

The European Medicines Agency has validated a Type II Variation Marketing Authorization Application to Karyopharm Therapeutics Inc. for selinexor in combination with bortezomib and low-dose dexamethasone as a treatment for adult patients with multiple myeloma who have received at least 1 prior therapy.

FDA Approves Loncastuximab Tesirine for Relapsed/Refractory Large B-Cell Lymphoma

April 23rd 2021

The FDA has granted an accelerated approval to loncastuximab tesirine (Zynlonta) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma following 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

Venetoclax-Based Regimens Get European Nod for Newly Diagnosed, Chemo-Ineligible AML

April 23rd 2021

The European Medicines Agency Committee for Medicinal Products for Human Use has recommended to approve venetoclax for use in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.

EU Panel Recommends Nivolumab/Ipilimumab in Frontline Unresectable Malignant Pleural Mesothelioma

April 23rd 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of nivolumab and ipilimumab as a frontline treatment for adult patients with unresectable malignant pleural mesothelioma.

Oral Azacitidine Recommended for EU Approval in AML

April 23rd 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion for the approval of oral azacitidine as a maintenance treatment for adult patients with acute myeloid leukemia who had a complete remission or CR with incomplete blood count recovery after induction therapy with or without consolidation treatment, and who are ineligible for or choose to not undergo hematopoietic stem cell transplant

Dostarlimab Approved in Europe for Advanced dMMR Endometrial Cancer

April 23rd 2021

The European Commission has granted conditional marketing authorization to dostarlimab for the treatment of patients with microsatellite instability–high/mismatch repair deficient recurrent or advanced endometrial cancer who have progressed on or following prior therapy with a platinum-containing regimen.