FDA Approvals Boost Competition in Treatment Landscapes

Published: Saturday, Jan 18, 2020
Therapeutic developments in cancer were rewarded with a wave of approvals in 2019. Tumor types such as breast cancer and prostate cancer saw multiple approvals, while continued research offered more targeted therapies across cancer types. May was the busiest month, with 8 new indications and the novel drug approval of alpelisib (Piqray) in combination with fulvestrant for hormone receptor–positive, HER2-negative, PIK3CA-mutated metastatic breast cancer.

-positive pancreatic cancer.

Table. The Year in Innovation (Click to Enlarge)

Luspatercept-aamt (Reblozyl) shook up the hematology space in November with an approval for the treatment of anemia in adult patients with ß-thalassemia who require red blood cell transfusions.

Elsewhere in the treatment landscape, there were several approvals for drugs to be used earlier for earlier stages of prostate cancer: enzalutamide (Xtandi) and apalutamide (Erleada) for metastatic castration-sensitive disease and darolutamide (Nubeqa) for nonmetastatic castration-resistant tumors. The FDA has now approved 3 drugs in this space based on metastasis-free survival.

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