A Look Back at FDA News from December 2018


A look back at all the FDA news that happened in the month of December 2018, including several new approvals, an accelerated approval, and a priority review.

In December 2018, the FDA approved several new indications, including for the treatment of non—small cell lung cancer (NSCLC), immune thrombocytopenia (ITP), ovarian cancer, blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute lymphoblastic leukemia (ALL), and paroxysmal nocturnal hemoglobinuria (PNH). There was also an accelerated approval in Merkel cell carcinoma (MCC) and a priority review granted for small cell lung cancer (SCLC).

FDA Grants Atezolizumab Plus Chemotherapy Regimen Priority Review for Frontline SCLC

Here’s a look back at all the FDA happenings in the month of December 2018:

FDA Grants Approval to Frontline Atezolizumab Regimen for NSCLC

On December 5, 2018, the FDA granted a priority review to atezolizumab (Tecentriq) for combination use with carboplatin and etoposide for the treatment of patients with extensive-stage SCLC in the first-line. This decision was based on findings from the phase III IMpower133 trial.

Romiplostim Receives FDA Approval for Pediatric ITP

The FDA approved atezolizumab in combination with bevacizumab (Avastin), carboplatin, and paclitaxel (ABCP) for the frontline treatment of patients with metastatic nonsquamous NSCLC, excluding patients with EGFR/ALK aberrations. This approval was announced on December 6, 2018.

On December 14, 2018, the FDA approved romiplostim (Nplate) for the treatment of pediatric patients aged ≥1 year with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Trastuzumab Biosimilar Approved by FDA for HER2+ Breast Cancer

FDA Approves Olaparib as Frontline Maintenance Therapy in Ovarian Cancer

The FDA approved CT-P6 (Herzuma; trastuzumab-pkrb), a trastuzumab (Herceptin) biosimilar, on December 17, 2018. This biosimilar was approved for the treatment of patients with HER2-overexpressing breast cancer

Pembrolizumab Granted Accelerated FDA Approval in Merkel Cell Carcinoma

The FDA approved olaparib (Lynparza) on December 19, 2018, as a maintenance therapy for patients with deleterious or suspected deleterious germline or somaticBRCA-mutated advanced, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy, as approved by an FDA-approved companion diagnostic assay.

Tagraxofusp Approved by FDA for BPDCN

On December 19, 2018, the FDA granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic MCC. This approval was based on findings from the phase II CITN-09/KEYNOTE-017 trial.

Longer-Acting Calaspargase Pegol-mknl Receives FDA Approval in ALL

The FDA approved Tagraxofusp-erzs (SL-401; Elzonris) infusion on December 21, 2018, for tge treatment of both adult and pediatric patients aged ≥2 years, with BPDNC.

On December 21, 2018, the FDA approved a longer-acting version of calaspargase pegol-mknl (Asparlas) as a component of a multiagent chemotherapy regimen for pediatric and young adult patients aged 1 month to 21 years with ALL.

Ravulizumab Approved by FDA for Paroxysmal Nocturnal Hemoglobinuria

The FDA approved ravulizumab-cwvz (Ultomiris) as an injection on December 27, 2018, for adults with PNH, a rare blood disorder that leads to hemolysis.

A number of experts also shared their thoughts on some of the most impactful approvals seen in 2018.Check out this round up of the 2018 FDA approvals.

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