FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD


August 01, 2018

In This Article

New Indications/Other Oncology Updates

Breast Cancer: Lynparza (olaparib)

First PARP inhibitor approved for deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, in patients who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.

Cervical Cancer/Large B-Cell Lymphoma: Keytruda (pembrolizumab)

New indications approved for the following:

  • Recurrent or metastatic cervical cancer in patients with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1)

  • Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL) or who have relapsed after 2 or more prior lines of therapy

Hematopoietic Syndrome of Acute Radiation Syndrome: Leukine (sargramostim)

Indicated to increase survival in adults and children acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome [H-ARS]).

Large B-Cell Lymphoma: Kymriah (tisagenlecleucel)

New indication for adults with relapsed or refractory diffuse large B-cell lymphoma (r/rDLBCL) who are ineligible for or relapsed after ASCT.

Multiple Myeloma: Xgeva (denosumab)

Indication expanded for prevention of skeletal-related events (SREs); expanded to include patients with multiple myeloma. Originally approved to prevent SREs in patients solid tumors.

Non-Small Cell Lung Cancer: Imfinzi (durvalumab)

Indicated for unresectable, stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Other Oncology Updates

The FDA-approved indications for Keytruda (pembrolizumab) or Tecentriq (atezolizumab) have been revised for patients with locally advanced or metastatic urothelial carcinoma.

These revisions are a result of an early review by the data monitoring committee of ongoing clinical trials exploring first-line therapy that showed decreased survival when a checkpoint inhibitor (ie, pembrolizumab or atezolizumab) was used as monotherapy for metastatic urothelial cancer. The trials compared treatment-naive patients receiving pembrolizumab or atezolizumab with a platinum-based chemotherapy (a cisplatin- or carboplatin-based regimen) who had low protein programmed death ligand 1 (PD-L1) expression. Please refer to the following for the precise wording of the revised indications.

Indicated for the following patients with locally advanced or metastatic urothelial carcinoma:

  • Those who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (atezolizumab IC covering ≥5% of the tumor area, or pembrolizumab CPS ≥10), OR

  • Those who are not eligible for any platinum-containing chemotherapy regardless of level of tumor PD-L1 expression, OR

  • Those who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy



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