Overview of Blockbuster Drugs in Oncology Approved in 2022, in the Pipeline for Approval in 2023

Pharmacy Times interviewed Ray Tancredi, divisional vice president of Specialty Pharmacy, Development & Brand Rx/Vaccine Purchasing at Walgreens, on his presentation at the Asembia Summit 2022 on specialty pharmaceutical pipeline updates.

Question: What are some blockbuster drugs in the oncology space that have recently been approved, and how have they impacted the field since their approval?

Ray Tancredi: Yeah, when you think about that, the FDA approved, probably, I think 58 drugs in 2021, and a number of them were oncology. A number of them could have blockbuster status, including a couple of oncology drugs. I think the 10-year average for FDA approvals was 48. So think about COVID-19, and how that might have impacted clinical trials and bringing drugs to market.

I think we're on the verge of an even bigger year from a number of approvals perspective. But to answer your question, I think 2 drugs were approved recently that could be over $1 billion dollars in sales as they move ahead, and that's [idecabtagene vicleucel (Abecma)] by BMS for multiple myeloma, it's a [chimeric antigen receptor (CAR) T cell immunotherapy]—could be over $1 billion dollars, I read somewhere it could be $1.4 billion a year. I think also, you saw a product, [sotorasib (Lumakras)] from Amgen for metastatic non-small lung carcinoma, that could be over $1 billion dollars in sales.

I think those 2 drugs were the recent approvals in oncology that will make an impact by their cost, and by their effectiveness for those disease states. But it doesn't end there. I think in 2021, you saw a number of products that you could consider blockbusters—[inclisiran (Leqvio)] from Novartis. They're predicting $1.7 billion in sales by 2026, and that's a cholesterol-lowering agent.

Amgen brought a severe asthma add-on maintenance therapy, called [tezepelumab-ekko (Tezspire)], that could be over $1 billion dollars a year product. Argenx brought a product for generalized myasthenia gravis that could also be labeled a blockbuster. Then Aurinia Pharmaceuticals brought [voclosporin (Lupkynistm)], which is for lupus nephritis and also has a price tag of over $1 billion dollars a year.

So as you can see, 2021 had a number of products that we could potentially consider blockbuster drugs, especially as these products get expanded labels or carve out share within their therapy area. So all in all, very successful year, a lot of products in the market that are going to bring value to physicians, patients, and pharmacists in the pharmaceutical industry. A couple of them are oncology and many other disease states are included.

Question: So far this year, have any game-changing therapies come to market?

Ray Tancredi: When you think of game changers, I think I named a number of them in that last set of drugs, I mean, every one of those products that I mentioned are game changers. That's why they're going to be so highly utilized.

I told you the 2 oncology drugs and the other product is that [inclisiran (Leqvio)] by Novartis, that product is going to be extremely efficacious. Again, almost $2 billion in sales by 2026.

A product that may not be considered specialty, but was approved in COVID-19—even Pfizer's product—it's a vaccine called [COVID-19 Vaccine, mRNA (Comirnaty)]. It could be, once it goes commercial right now—it's still in EUA use—but once it goes commercial it could be a $1.4 billion product. I think the game changer for asthma that add-on therapy [tezepelumab-ekko (Tezspire)] for severe asthma, it's maintenance add-on, [and it] could be a game changer in the asthma space.

Question: What drugs will you be watching post-2022 in terms of FDA assessment and approval, and what may be the impact of these drugs hitting the market, if they’re approved?

Ray Tancredi: Yeah, I think there's a drug in early 2023 called bempegaldesleukin for renal cell carcinoma. When you think of renal cell carcinoma, there's a number of products in the marketplace today. It's really the most common type of kidney cancer, and renal cell carcinoma is the eighth most common cancer in the United States. You see about 80,000 new cases per year and close to 14,000 deaths in 2021. There are a number of combination therapies, but bempegaldesleukin will be a product that will impact the marketplace from an efficacy perspective and a cost perspective.

Then [there are] 3 other drugs I think you'll see in early 2022 that I have my eyes on. One is for breast cancer called elacestrant from the Menarini Group, you have [pegcetacoplan (Empaveli)] for acute macular degeneration from Apellis [Pharmaceuticals], and magrolimab for myelodysplastic syndrome from Gilead [Sciences]. So I think those 4 products we can look to in early 2022 to make an impact to the market.