TargetedOnc Staff Writer

According to a statement from the FDA, the agency has issued a draft guidance proposing labeling recommendations for breast implant manufacturers that would help patients understand the benefits and risks of implants. The labeling recommendations would include the addition of a boxed warning.

Aiwu Ruth He, MD, PhD, discusses treatment options in a&nbsp;<em>Targeted Oncology </em>live case-based peer perspectives discussion&nbsp;based on 2 case studies of patients with hepatocellular carcinoma.&nbsp;

Copanlisib has been granted with a breakthrough therapy designation from the FDA for the&nbsp;treatment of adult patients with relapsed marginal zone lymphoma who have received at least 2 prior therapies.

The review period on the new drug application for quizartinib as a treatment for adult patients with&nbsp;relapsed/refractory <em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia has been extended by the FDA by 3 months.&nbsp;This provides the FDA with additional time to review more data supplied by&nbsp;Daiichi Sankyo, the manufacturer of the FLT3 inhibitor.

An accelerated approval has been granted by the FDA for the combination of&nbsp;atezolizumab and nab-paclitaxel as a frontline treatment for patients with&nbsp;unresectable locally advanced or metastatic PD-L1&ndash;positive triple-negative breast cancer.