FDA approvals in hematology and oncology: Novel agents and new tricks for old drugs
In this episode, we review drugs recently approved by the Food and Drug Administration in the hematology/oncology space.
David M. Mintzer, MD, of Pennsylvania Hospital, joins host David H. Henry, MD, to highlight some first-time approvals and new indications for older drugs.
Approvals in 2020
Pembrolizumab (Keytruda) was approved for a range of new indications last year, including:
Avelumab (Bavencio) was approved for maintenance therapy in patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. https://bit.ly/3ar8XOs.
Nivolumab (Opdivo) was approved for:
Atezolizumab (Tecentriq) was approved in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. https://bit.ly/2NzkodG.
Osimertinib (Tagrisso) was approved for adjuvant therapy after tumor resection in patients with non–small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. https://bit.ly/2NC0aQs.
Selinexor (Xpovio) was approved for:
The FDA also approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) for subcutaneous injection for:
Relugolix (Orgovyx) was the first oral gonadotropin-releasing hormone receptor antagonist approved by the FDA for adults with advanced prostate cancer. https://bit.ly/3qyJisQ.
Approvals in 2021
Cemiplimab-rwlc (Libtayo) was approved for patients with locally advanced or metastatic basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. https://bit.ly/3ppkW31.
Daratumumab plus hyaluronidase (Darzalex Faspro) was approved in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis. https://bit.ly/3bbaF5I.
Approval in 2019
In late 2019, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. https://bit.ly/3qw9tA4.
Show notes written by Sheila DeYoung, DO, a resident at Pennsylvania Hospital, Philadelphia.
Disclosures
Dr. Mintzer and Dr. Henry have no relevant disclosures.
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David Henry on Twitter: @davidhenrymd
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