Overview of successful oncology drugs approved in 2022, pending approval in 2023

Overview of successful oncology drugs approved in 2022, pending approval in 2023

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

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

Ray Tancredi: Yes, if you think about it, the FDA probably approved, I think 58 drugs in 2021 and some of them were oncology. Some of them may have blockbuster status, including a couple of cancer drugs. I think the 10-year average for FDA approvals was 48. So think about COVID-19 and how that may have affected clinical trials and getting drugs to market.

I think we’re on the verge of an even bigger year from an endorsement standpoint. But to answer your question, I think 2 drugs have recently been approved that could exceed $ 1 billion in sales as they go, and this is [idecabtagene vicleucel (Abecma)] from BMS for multiple myeloma, it is a [chimeric antigen receptor (CAR) T cell immunotherapy]—It could be more than $ 1 billion, I read somewhere it could be $ 1.4 billion a year. I also think you have seen a product, [sotorasib (Lumakras)] by Amgen for metastatic non-small lung cancer, which could exceed $ 1 billion in sales.

I think those 2 drugs were the recent oncology approvals that will impact their cost and effectiveness for those disease states. But it doesn’t stop there. I think in 2021 you saw a number of products that you might consider blockbusters—[inclisiran (Leqvio)] by Novartis. They expect sales of $ 1.7 billion by 2026, and this is a cholesterol-lowering agent.

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

So, as you can see, 2021 has had a number of products that we could potentially see as successful drugs, especially as these products get expanded labels or carve shares within their therapeutic area. So all in all, a very successful year, many products on the market that will bring value to doctors, patients and pharmacists in the pharmaceutical industry. A couple of these are oncology and many other disease states are included.

Request: Have revolutionary therapies hit the market so far this year?

Ray Tancredi: When you think about game changers, I think I’ve named a few in that last set of drugs, I mean, every one of those products I mentioned are game changers. That is why they will be so widely used.

I told you the 2 cancer drugs and the other product is that [inclisiran (Leqvio)] from Novartis, that product will be extremely effective. Again, nearly $ 2 billion in sales by 2026.

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

Request: What drugs will you look at after 2022 in terms of FDA evaluation and approval, and what could be the impact of these drugs hitting the market if approved?

Ray Tancredi: Yes, I think in early 2023 there is a drug called bempegaldesleukin for renal cell carcinoma. When it comes to renal cell carcinoma, there are a number of products on the market today. It is indeed the most common type of kidney cancer, and renal cell carcinoma is the eighth most common cancer in the United States. There are about 80,000 new cases per year and nearly 14,000 deaths in 2021. There are a number of combination therapies, but bempegaldesleukin will be a product that will impact the market in terms of effectiveness and cost.

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


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