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A Look Back at FDA News from November 2019

Danielle Ternyila
Published Online:3:49 PM, Mon December 2, 2019
In November 2019, the FDA approved a number of treatments, including acalabrutinib (Calquence) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), as well as zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL). A biosimilar for pegfilgrastim (Neulasta) was also approved under indications.

The FDA also granted priority review designations, orphan drug designations, and accepted applications for review.

Here’s a look back on the FDA happenings from the month of November 2019: 

Pegfilgrastim Biosimilar from Sandoz Approved by the FDA

On November 5, 2019, the FDA approved pegfilgrastim-bmez (LA-EP2006; Ziextenzo), a biosimilar of pegfilgrastim, to decrease the incidence of infection caused by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive therapy.

FDA Grants Orphan Drug Designation to TT-00420 for Treatment of Cholangiocarcinoma

The investigational spectrum-selective multiple kinase inhibitor, TT-00420, received an orphan drug designation on November 8, 2019, from the FDA for the treatment of cholangiocarcinoma.

FDA Approves Luspatercept for Anemia Associated With Beta Thalassemia

The FDA approved luspatercept-aamt (Reblozyl) on November 8, 2019, for the treatment of anemia in adult patients with beta thalassemia who need regular red blood cell (RBC) transfusions.

FDA Grants Priority Review for Nivolumab Plus Ipilimumab in Advanced HCC

On November 11, 2019, the FDA granted a priority review designation to the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) for the treatment of advanced hepatocellular carcinoma (HCC) previously treated with sorafenib (Nexavar).

Ibrutinib/Rituximab Seeking Approval As Frontline Treatment for CLL

A supplemental New Drug Application (sNDA) for the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) was submitted to the FDA on November 12, 2019, for frontline treatment of patients aged 70 years or younger with CLL or SLL.

FDA Grants Priority Review to Selumetinib for Neurofibromatosis Type 1 in Pediatric Patients

The FDA granted a priority review designation to selumetinib (AZD6244) for the treatment of patients who are ≥3 years old with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas on November 14, 2019.

FDA Approves Zanubrutinib for Previously Treated MCL

The FDA granted an accelerated approval on November 14, 2019, to zanubrutinib for the treatment of adult patients with MCL who have received at least 1 prior therapy.

FDA to Review BLA of SB8 Biosimilar to Bevacizumab

On November 19, 2019, the FDA accepted a Biologics License Application (BLA) for SB8, a biosimilar candidate to reference bevacizumab (Avastin) that was submitted by Samsung Bioepis in September 2019.

FDA Approves Acalabrutinib for CLL/SLL

The FDA approved acalabrutinib (Calquence) on November 21, 2019, for the treatment of adult patients with CLL or SLL as either an initial or subsequent therapy.

Surufatinib Granted FDA Orphan Drug Designation for Treatment of NETs

On November 26, 2019, surufatinib (HMPL-012) has been granted FDA Orphan Drug Designation for the treatment of pancreatic neuroendocrine tumors (NETs).

Pemigatinib Granted Priority Review by FDA for Treatment of Cholangiocarcinoma

The FDA granted a priority review designation on November 27, 2019, to pemigatinib, as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

Durvalumab sBLA Granted Priority Review by the FDA

On November 29, 2019, the FDA granted priority review to durvalumab (Imfinzi) for the treatment of previously untreated extensive-stage small cell lung cancer.

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