Replies to post #240837 on Biotech Values

[DewDiligence]

Addendum—Some stemcell-transplant surgeons claim to be “unimpressed” with such CAR-T therapies as Yescarta and Breyanzi. The reason for such a viewpoint, sadly, may be that these specialists are worried about losing business.

[DewDiligence]

FDA approves GILD’s Yescarta for second-line LBCL:

https://www.businesswire.com/news/home/20220401005519/en

This is the first approval of any CAR-T in the second-line (as opposed to third-line or later) setting.

BMY’s Breyanzi in under FDA review for the same indication; the PDUFA date is 6/24/22.

[DewDiligence]

FDA approves BMY’s Breyanzi for second-line LBCL:

https://www.businesswire.com/news/home/20220427005982/en

The approval is based on phase-3 data reported one year ago, in which Breyanzi showed statsig-superior EFS compared to SoC (#msg-164317285).

Breyanzi will compete in this newly approved indication with GILD’s Yescarta (#msg-167110232).

Breyanzi was initially FDA-approved for third-line LBCL in Feb 2021 (#msg-161552697). This is the drug at the heart of the lawsuit by former CELG shareholders (#msg-169238809).

[DewDiligence]

BMY’s Breyanzi continues to show robust results in second-line LBCL after longer follow-up:

https://www.fiercepharma.com/pharma/bristol-myers-bolsters-breyanzis-earlier-lymphoma-case-elevated-car-t-fight-against-gilead-0

Data from the same trial presented one year ago (at ASH 2021) are in #msg-164317285.