A Look Back at FDA News from March 2019

A look back at all the FDA news that happened in March 2019, including several new approvals, a clinical hold, an orphan drug designation, and more.

In March 2019, the FDA approved several agents, including therapies for the treatment of small cell lung cancer (SCLC) and triple-negative breast cancer (TNBC), as well as a fourth trastuzumab (Herceptin) biosimilar. The FDA also put a clinical hold on venetoclax (Venclexta) trials in multiple myeloma, and granted an orphan drug designation for the treatment of patients with T-cell prolymphocytic leukemia.

FDA Gives Fedratinib Priority Review Designation for Myelofibrosis

Here’s a look back on the FDA happenings for the month of March 2019:

sNDA Submitted to FDA for Approval of Venetoclax/Obinutuzumab in Treatment Naïve CLL

On March 5, 2019, the FDA granted a priority review designation to fedratinib, a highly selective JAK2 inhibitor, for the treatment of patients with myelofibrosis. This decision was based on data from the phase III JAKARTA and phase II JAKARTA-2 trials.

Atezolizumab/Nab-Paclitaxel Approved by the FDA for PD-L1+ TNBC

On March 7, 2019, a supplemental new drug application (sNDA) was submitted to the FDA seeking approval for the combination of venetoclax and obinutuzumab (Gazyva) for the treatment of patients with previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions.

The combination atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) was approved by the FDA for the treatment of newly diagnosed patients with unresectable locally advanced or metastatic PD-L1-positive TNBC on March 8, 2019.

Fourth Trastuzumab Biosimilar Granted Approval by FDA

The FDA granted approval to the fourth trastuzumab biosimilar on March 11, 2019. This biosimilar is approved for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

FDA Extends Review of Selinexor Application for Myeloma

On March 15, 2019, the FDA added 3 months to the review period for the NDA seeking the approval of selinexor for the treatment of patients with penta-refractory multiple myeloma. The new action date will be July 6, 2019.

Atezolizumab Triplet Approved by FDA for Frontline SCLC

The FDA granted approval on March 19, 2019, to the triplet regimen of atezolizumab, carboplatin, and etoposide as a frontline treatment for patients with extensive-stage SCLC. The FDA based this approval on the data from the phase III IMpower133 trial.

FDA Puts Enrollment Hold on Venetoclax Myeloma Trials

On March 19, 2019, the FDA placed a partial clinical hold on all clinical trials examining venetoclax in multiple myeloma. The decision was based on safety data from the ongoing phase III BELLINI trial (M14-031; NCT02755597) where results showed a higher rate of patient deaths with the combination venetoclax plus bortezomib (Velcade) and dexamethasone (Vd) versus placebo plus Vd in relapsed/refractory multiple myeloma.

Approval Sought for Frontline Daratumumab Combo in Transplant-Eligible Myeloma

The FDA received a supplemental biologics license application on March 26, 2019, for a new indication of daratumumab (Darzalex). The sBLA seeks approval for the combination of daratumumab plus bortezomib, thalidomide (Thalomid), and dexamethasone (VTD) for the frontline treatment of patients with multiple myeloma who are eligible for autologous stem cell transplant.

FDA Grants Ivosidenib Combo Breakthrough Therapy Designation for IDH1+ AML

On March 27, 2019, the FDA granted the combination of ivosidenib (Tibsovo) plus azacitidine (Vidaza) a breakthrough therapy designation for the treatment of newly diagnosed patients with acute myeloid leukemia (AML) who harbor anIDH1mutation and are over 75 years old or have comorbidities that would prevent them from receiving intensive induction chemotherapy.

FDA Proposes Updates to Mammography Standards for First Time in 20 Years

Amendments to key policies to modernize breast cancer screening and improve mammography services were proposed by the FDA on March 27, 2019. The proposal would modify regulations that were issued under the Mammography Quality Standards Act (MQSA) of 1992, marking the first time this has been modified in 20 years.

Novel Agent Granted Orphan Drug Designation for T-Cell Prolymphocytic Leukemia