FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD

Disclosures

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

Reference:

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....