FDA Approves First Targeted Therapeutic for BRCA-mutant Breast Cancer

On Friday, the U.S. Food and Drug Administration (FDA) approved the molecularly targeted therapeutic olaparib (Lynparza) for treating certain patients with metastatic, HER2-negative breast cancer. The FDA also granted marketing authorization for a test to identify those patients eligible to receive olaparib: patients with an inherited, cancer-associated BRCA1 or BRCA2 (BRCA1/2) mutation.

Read More

Biosimilars: Breaking Through to Cancer Treatment

A little-talked-about provision of the 2010 Patient Protection and Affordable Care Act designed to improve access to innovative medical therapies has recently borne fruit for the cancer community in the form of two new therapeutic options for a wide range of cancers—bevacizumab-awwb (Mvasi) and trastuzumab-dkst (Ogivri).

Read More

Vemurafenib Becomes First FDA-approved Treatment for a Rare Type of Blood Cancer

Recently, the U.S. Food and Drug Administration (FDA) approved the molecularly targeted therapeutic vemurafenib (Zelboraf) for treating certain adults who have a rare type of blood cancer called Erdheim-Chester disease. Vemurafenib targets mutant forms of the protein BRAF, and it has been approved for treating those patients whose Erdheim-Chester disease harbors the BRAF V600 mutation.

Read More

FDA Approves New Treatment Option for Breast Cancer

Last week, the U.S. Food and Drug Administration (FDA) provided some good news for the breast cancer community just days before the start of breast cancer awareness month when it added a new molecularly targeted therapeutic to the armamentarium for oncologists treating patients with breast cancer: abemaciclib (Verzenio).

Read More

FDA Approvals for Liver and Stomach Cancer Extend the Reach of Immunotherapy

Last week, the U.S. Food and Drug Administration (FDA) increased the number of types of cancer for which immunotherapeutics known as checkpoint inhibitors are a treatment option when it expanded the approved uses of nivolumab (Opdivo) and pembrolizumab (Keytruda) to include certain patients with liver cancer and stomach cancer, respectively.

Read More

FDA Approves New Molecularly Targeted Therapeutic for Non-Hodgkin Lymphoma

The flurry of treatments approved by the U.S. Food and Drug Administration (FDA) for treating hematological malignancies continued last week with the approval of the molecularly targeted therapeutic copanlisib (Aliqopa) for the treatment of certain adults with non-Hodgkin lymphoma.

Read More

New Treatment for Adults with Acute Lymphoblastic Leukemia Approved by the FDA

This week’s excitement surrounding the groundbreaking U.S. Food and Drug Administration (FDA) approval of the CAR T–cell therapy tisagenlecleucel (Kymriah) for treating certain pediatric and young adult patients with acute lymphoblastic leukemia (ALL) was not the only good news for ALL community in August. Earlier in the month, the FDA approved a new molecularly targeted therapeutic called inotuzumab ozogamicin (Besponsa) for treating adults who have B-cell precursor ALL that did not respond to initial treatment or that returned after treatment.

Read More