FDA Oncology Approval From Spring 2023

The world of oncology continues to advance at a rapid pace, as multiple new drugs have been approved for various cancer types — both solid and hematologic malignancies — over the last few months. There are also new therapies in the pipeline, too, as ongoing clinical trials are leading to New Drug Applications, Priority Reviews and more from the Food and Drug Administration (FDA).

READ MORE: A Breakdown of Food and Drug Administration Decisions

In case you missed it, here is an overview of new regimens that gained FDA approval this spring.

Here is a list of five FDA approvals in the oncology space that happened in the spring of 2023.

Zynyz for metastatic Merkel cell carcinoma.

In March, the FDA approved Zynyz (retifanlimab-dlwr) for patients with metastatic or locally recurrent Merkel cell carcinoma — a rare type of skin cancer. The approval, which was based off findings from the PODIUM-201 trial, marks the first PD-1 inhibitor (a type of drug that blocks the PD-1 protein on cancer cells, thereby preventing them from hiding from the immune system) to be approved for this patient population.

Lynparza plus abiraterone for BRCA-mutant prostate cancer.

The FDA approved Lynparza (Olaparib) plus abiraterone and prednisone for patients with deleterious or suspected deleterious BRCA-mutant castration-resistant prostate cancer, based on findings from the PROpel clinical trial, which showed that adding Lynparza to abiraterone significantly improved the time patients lived before their disease got worse (an endpoint known as progression-free survival) compared with placebo plus abiraterone.

Polivy combination for diffuse large B-cell lymphoma.

Polivy (polatuzumabvedotin-piiq) plus Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone was approved in April for patients with previously untreated diffuse large B-cell lymphoma (DLBCL), ending a nearly 20-year period where no new options were approved for this patient population. The approval was based on findings from the POLARIX trial, which showed that the newly approved regimen led to a 27% reduction in the risk of disease progression or death compared with the current standard of care.

Padcev plus Keytruda for advanced bladder cancer.

Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) was granted an accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma (a type of bladder cancer) who are not eligible to receive cisplatin-based chemotherapy, a group that, according to one expert, is comprised of approximately 8,000 to 9,000 patients in the United States. Two clinical trials — EV-103 and KEYNOTE-869 — led to the regimen’s approval, after they showed that the majority of patients given Padcev plus Keytruda experienced a response, while 12% had their disease completely disappear.

Epkinly for relapsed/refractory diffuse large B-cell lymphoma.

In May, the FDA approved another regimen — Epkinly (epcoritamab-bysp) — for DLBCL, this time for patients with relapsed or refractory disease or for those with disease that is the result of indolent lymphoma and high-grade B-cell lymphoma that has been treated with two or more lines of therapy. The FDA made the approval decision based on findings from the EPCORE NHL-1 trial, which showed that 61% of patients responded to the treatment (meaning that their cancer shrank or disappeared), with 38% of patients experiencing a complete response, meaning that there were no signs of cancer after treatment.

New therapies are constantly being investigated in the cancer space. To keep track of ongoing clinical trials that patients can be a part of, follow CURE®’s Clinical Trial Corner page. Or, to receive the latest breaking news regarding oncology-related FDA approvals, follow CURE® on Facebook, Twitter and Instagram, or sign up for our eNews alerts.

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