FDA Approves a New PARP Inhibitor for BRCA-mutant Breast Cancer

In the midst of Breast Cancer Awareness Month, the US. Food and Drug Administration (FDA) provided good news for the breast cancer community this week when it approved a new breast cancer therapeutic called talazoparib (Talzenna), which targets ADP-ribose polymerase (PARP) proteins. They also approved a test to identify those patients eligible to receive talazoparib: patients with metastatic or locally advanced, HER2-negative breast cancer who have an inherited, cancer-associated BRCA1 or BRCA2 (BRCA1/2) mutation.

Read More

Three New Cancer Treatments Approved by the FDA

Last week saw a flurry of new anticancer therapeutics approved by the U.S. Food and Drug Administration (FDA) for treating several types of cancer. On Monday, Sept. 24, the agency approved the molecularly targeted therapeutic duvelisib (Copiktra) for treating certain patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and for treating certain patients with follicular lymphoma. On Thursday, Sept. 27, it approved another molecularly targeted therapeutic—dacomitinib (Vizimpro)—for treating certain patients with non–small cell lung cancer (NSCLC). Then, on Friday, Sept. 28, it approved the immunotherapeutic cemiplimab-rwlc (Libtayo) for treating certain patients with cutaneous squamous cell carcinoma.

Read More

Harnessing the Power of Precision Medicine – Treating Cancers with Tissue-agnostic Therapies

Cancer treatments have been, and continue to be in most cases, based on the organ site where the tumor originates—some treatments are specific for breast cancer, some for lung cancer, and so on. However, rapid advances in genomic sequencing technologies have led to a recent development that deviates from the long-held notion of treating cancers based on the site of origin.

Read More

AACR Applauds FDA’s New Steps to Address Epidemic of Youth E-cigarette Use

In 2017, electronic cigarettes (e-cigarettes) were the most commonly used tobacco product among high and middle school students. Many public health experts believe that youth use of e-cigarettes has reached an epidemic proportion.

On September 12, 2018, the U.S. Food and Drug Administration (FDA) announced a series of critical and historic enforcement actions related to the sale and marketing of e-cigarettes to kids. This effort included issuing more than 1,300 warning letters and fines to retailers who illegally sold e-cigarette products to minors.

Read More

Recent FDA Approvals Signal More Progress Against Cancer

The past month has seen the U.S. Food and Drug Administration (FDA) expand the use of four anticancer therapeutics, providing new treatment options for patients with four types of cancer. On Aug. 16, 2018, the agency approved the immunotherapeutic nivolumab (Opdivo) for treating certain patients with small cell lung cancer and approved the molecularly targeted therapeutic lenvatinib (Lenvima) for treating certain patients with the most common type of liver cancer, hepatocellular carcinoma.

Read More

FDA Expands Use of Pembrolizumab to Two Additional Cancer Types

Last week, the U.S. Food and Drug Administration (FDA) increased the number of types of cancer for which pembrolizumab (Keytruda) is a treatment option when it approved the immunotherapeutic for treating certain patients with cervical cancer and certain patients with non-Hodgkin lymphoma.

Read More

FDA Approves Targeted Therapy Combo for Thyroid Cancer

On May 4, the U.S. Food and Drug Administration (FDA) approved a combination of molecularly targeted therapeutics for the treatment of a certain type of thyroid cancer. Specifically, the FDA approved the use of dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for treating patients who have anaplastic thyroid cancer that cannot be removed by surgery or that has metastasized, and that tests positive for a BRAF V600E gene mutation.

Read More