accelerated approval

January 28, 2020January 28, 2020

TG Therapeutics Seeks Accelerated FDA Approval of Umbralisib for Marginal Zone and Follicular Lymphomas

News

TG Therapeutics is seeking accelerated approval in the U.S. for its investigational oral therapy umbralisib to treat patients with marginal zone lymphoma (MZL) and follicular lymphoma (FL) who failed to ... Read more

November 19, 2019November 19, 2019

FDA Approves BeiGene’s Brukinsa to Treat Adults with Mantle Cell Lymphoma

News

The U.S. Food and Drug Administration (FDA) has granted conditional approval to BeiGene’s Brukinsa (zanubrutinib) as a second-line treatment for adults with mantle cell lymphoma (MCL) who have received at least ... Read more

July 11, 2019

TG Therapeutics to Seek Accelerated Approval of Umbralisib for Marginal Zone Lymphoma

News

After positive feedback from the U.S. Food and Drug Administration, TG Therapeutics is planning to pursue accelerated approval for umbralisib (TGR-1202) as a treatment for patients with marginal zone lymphoma (MZL). ... Read more

June 13, 2019June 20, 2019

FDA Gives OK to Polivy plus Rituxan-Bendamustine Combo to Treat Advanced DLBCL

News

The U.S. Food and Drug Administration (FDA) has approved — with conditions — Genentech‘s Polivy (polatuzumab vedotin-piiq), used in combination with Rituxan (rituximab) and bendamustine (a chemotherapy), to treat adults with relapsed or ... Read more

January 11, 2019

Epizyme Planning to Request FDA’s Accelerated Approval of Tazemetostat for Follicular Lymphoma Patients

News

Epizyme plans to ask the U.S. Food and Drug Administration (FDA) for accelerated approval of tazemetostat as a treatment for people with relapsed or refractory follicular lymphoma with or without EZH2 activating mutations. ... Read more

April 12, 2018June 22, 2018

FDA Grants Priority Review to Duvelisib for Two Lymphoma Types

News

The U.S. Food and Drug Administration (FDA) will review an application requesting duvelisib’s full approval for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for ... Read more

January 25, 2018

9 in 10 Mantle Cell Lymphoma Patients Benefit from Calquence, AstraZeneca Reports

News

Calquence (acalabrutinib) eliminated tumors in 40 percent of mantle cell lymphoma patients who took part in a Phase 2 clinical trial, AstraZeneca and Acerta Pharma reported. An additional 41 percent in the ACE-LY-004 trial ... Read more

November 1, 2017November 1, 2017

FDA Grants Accelerated Approval to Calquence for Mantle Cell Lymphoma

News

The U.S. Food and Drug Administration has approved AstraZeneca‘s Calquence (acalabrutinib) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The FDA’s accelerated ... Read more

March 16, 2017March 16, 2017

FDA Approves Keytruda for Heavily Treated Classical Hodgkin’s Lymphoma Patients

News

The anti-PD-1 immunotherapy Keytruda (pembrolizumab) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults and children with refractory classical Hodgkin’s lymphoma (cHL) who have ... Read more

January 20, 2017

FDA Approves Imbruvica for Certain Marginal Zone Lymphoma Patients

News

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Imbruvica (ibrutinib) for patients with marginal zone lymphoma (MZL) who have received at least one prior therapy containing ... Read more