FDA Approvals in Hematology and Oncology

In the last four months of 2019, the U.S. Food & Drug Administration approved 16 new drugs in the field of hematology and oncology. This is exciting news for cancer patients, because it means treatment options are continuing to evolve. From the approval of acalabrutinib (Calquence) for the treatment of chronic lymphocytic leukemia (CLL) to an accelerated approval of zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma, we have a lot of promising news to share.

After reviewing all of the recent FDA approvals, here are the seven most relevant to our Patient Power communities. Click on the links for more details:

BREAST CANCER

• FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive breast cancer (December 2019)

CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

• Project Orbis: FDA approves acalabrutinib for CLL and SLL (November 2019)

LUNG CANCER

• FDA approves atezolizumab with nab-paclitaxel and carboplatin for metastatic NSCLC without EGFR/ALK aberrations (December 2019)

MANTLE CELL LYMPHOMA

• FDA grants accelerated approval to zanubrutinib for mantle cell lymphoma (December 2019) 

MULTIPLE MYELOMA

• FDA approves daratumumab for transplant-eligible multiple myeloma (September 2019)

PROSTATE CANCER

• FDA approves enzalutamide for metastatic castration-sensitive prostate cancer (December 2019)
• FDA approves apalutamide for metastatic castration-sensitive prostate cancer (September 2019)

For more information and a complete list of FDA-approved drugs, visit the U.S. Food & Drug Administration’s Hematology/Oncology page at FDA.gov. To receive emerging news and research updates, subscribe to our Patient Power eNews and follow us on Facebook. 

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.