A Look Back at FDA News from July 2019

In July 2019, the FDA approved treatments for patients with chronic immune thrombocytopenia (ITP), non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), nonmetastatic castration-resistant prostate cancer (CRPC), and select patients with esophageal squamous cell carcinoma (ESCC). In addition, the FDA granted an accelerated approval in multiple myeloma, a fast track designation in diffuse large B-cell lymphoma (DLBCL), orphan drug designations in small cell lung cancer (SCLC) and acute myeloid leukemia (AML), a breakthrough designation in hepatocellular carcinoma (HCC), a priority review designation in epithelioid sarcoma, and a label update in stage III non—small cell lung cancer (NSCLC).

In addition, the FDA accepted 6 supplemental Biologics License Application (sBLA) with several other applications submitted to the FDA seeking approvals.

Here's a look back on the FDA happenings for the month of July 2019:

Neratinib Combo Seeking FDA Approval in HER2+ Metastatic Breast Cancer

A sNDA for neratinib (Nerlynx) was submitted to the FDA on July 1, 2019, for the potential approval for treatment in combination with capecitabine for patients with HER2-positive metastatic breast cancer who have progressed on ≥2 prior HER2-targeted treatments.

FDA Approves Avatrombopag for Chronic Immune Thrombocytopenia

An sNDA for avatrombopag (Doptelet) was approved by the FDA as treatment for adult patients with chronic ITP who have had an insufficient response to a prior therapy.

Selinexor Receives Accelerated FDA Approval for Heavily Pretreated R/R Multiple Myeloma

The FDA granted an accelerated approval on July 3, 2019, to selinexor (Xpovio) in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥4 prior therapies and whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 monoclonal antibody.

FDA Approval Sought for sBLAs for New Pembrolizumab Dosing Schedule

Six sBLAs were accepted by the FDA on July 9, 2019, for a potential update to the dosing schedule for pembrolizumab (Keytruda) for the following indications:

• Patients with unresectable or metastatic melanoma;
• Adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection;
• Adult and pediatric patients with refractory classical Hodgkin lymphoma, or those who have relapsed after ≥3 prior lines of therapy;
• Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed following ≥2 lines of prior therapy;
• Patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (combined positive score [CPS] ≥1);
• Patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar);
• Adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

FDA Grants Fast Track Designation to CLR 131 in DLBCL

On July 9, 2019, the FDA granted a fast track designation for CLR 131 as a potential treatment for patients with relapsed or refractory DLBCL.

FDA Reviewing Isatuximab BLA in Relapsed/Refractory Multiple Myeloma

The FDA accepted a BLA for isatuximab as a potential treatment for patients with relapsed or refractory multiple myeloma on July 10, 2019.

FDA Grants Durvalumab Orphan Drug Designation in SCLC

Durvalumab (Imfinzi) received an orphan drug designation on July 12, 2019, for the treatment of patients with SCLC.

Approval Sought for Subcutaneous Formulation of Daratumumab in Multiple Myeloma

A BLA was submitted to the FDA on July 12, 2019, for a new subcutaneous formulation of daratumumab (Darxalez) as treatment of select patients with multiple myeloma.

Enfortumab Vedotin BLA Seeking Approval in Locally Advanced/Metastatic Urothelial Cancer

On July 16, 2019, the FDA received a BLA for enfortumab vedotin seeking approval as a treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.

FDA Approves Label Update for Durvalumab in Stage III NSCLC to Include OS Data

The FDA approved an update to the label for durvalumab for patients with unresectable, stage III NSCLC whose disease has not progressed following concurrent platinum-based chemoradiotherapy to include overall survival data from the phase III PACIFIC trial.

Pembrolizumab/Lenvatinib Combo Gets FDA Breakthrough Designation for Newly Diagnosed, Unresectable HCC

On July 23, 2019, the FDA granted a breakthrough therapy designation to the combination of pembrolizumab plus lenvatinib (Lenvima) for the treatment of patients with newly diagnosed, advanced, unresectable HCC that is not amenable to locoregional treatment.

Rituximab Biosimilar Approved by FDA for CD20+ B-Cell NHL and CLL

On July 23, 2019, the rituximab (Rituxan) biosimilar PF-05280586 (rituximab-pvvr; Ruxience) was approved by the FDA as a single-agent or in combination with chemotherapy for the treatment of adult patients with CD20-positive B-cell NHL, or in combination with chemotherapy for patients with CD20-positive CLL.

FDA Grants Orphan Drug Designation to CD123-Targeted CAR T-cell Therapy for AML

The FDA granted an orphan drug designation on July 24, 2019, to MB-102, a CD123-directed chimeric antigen receptor (CAR) T-cell therapy for the treatment of patients with AML.

Tazemetostat Receives FDA Priority Review for Metastatic or Locally Advanced Epithelioid Sarcoma

On July 25, 2019, the FDA granted a priority review designation to the EZH2 inhibitor tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

Darolutamide Approved by FDA for Nonmetastatic CRPC

The FDA granted darolutamide (Nubeqa) on July 30, 2019, for the treatment of patients with nonmetastatic CRPC.

FDA Approves Pembrolizumab for PD-L1+ Esophageal Squamous Cell Carcinoma