The dates that Ayvakit and Tepezza received FDA approval to market was Jan. 9/20 and Jan. 21/20 as shown in the table as approval dates. Ofev received a BTD on July 16, 2014 and numerous market approvals since. On March 9/20 as in the table, it received FDA sales approval for the use laid out in the table. These are approvals to go to market, not BTD approvals. As I mentioned in an earlier post, it appears that BTD’s are GRANTED and then you go for an APPROVAL to go to market. I read an article that stated that the FDA is very strict on the use of these two words plus one more that is irrelevant to this. The article states that they are not interchangeable as far as the FDA is concerned but are often mistakenly done by the public and media.

The Yervoy and Opdivo approvals are for the same combination. They received an FDA Accelerated Approval on March10, 2020 (the date in the table). These are approvals for sale to the market, not BTD approvals. Below is a link to that FDA announcement and a couple of paragraphs from that release. You might find it interesting that they got this Acc. App. because of lack of treatment available. It might also be interesting for comparison to ZEN-3694.

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-nivolumab-and-ipilimumab-combination-hepatocellular-carcinoma

The main efficacy outcome measures were overall response rate  and duration of response as determined by blinded independent central review (BICR) using RECIST v1.1. ORR was 33% (n=16; 95% CI: 20, 48), with 4 complete responses and 12 partial responses. Response duration ranged from 4.6 to 30.5+ months, with 31% of responses lasting at least 24 months.

The most common adverse reactions (³20%) with nivolumab in combination with ipilimumab are: fatigue, diarrhea, rash, pruritus, nausea, musculoskeletal pain, pyrexia, cough, decreased appetite, vomiting, abdominal pain, dyspnea, upper respiratory tract infection, arthralgia, headache, hypothyroidism, decreased weight, and dizziness.