Oncolytics Biotech Inc T.ONC

Merck's Keytruda to gain 3rd approval for endometrial cancer

[Noteable]

February 03, 2023 - Merck's (MSD) Keytruda is already approved in two endometrial cancer indications in the U.S.

Keytruda is an example of a platform molecule, similar to ONCY's pelareorep, that is capable of being used in multiple cancers and then in multiple indications in each cancer type.

https://www.biospace.com/article/merck-eyes-third-endometrial-cancer-nod-for-keytruda-/

[Noteable]

Merck known as MSD outside of the United States and Canada, today announced that the Phase 3 NRG-GY018 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) met its primary endpoint of progression-free survival (PFS) for the treatment of patients with stage III-IV or recurrent endometrial carcinoma regardless of

[jimsenior]

ONC/ONCY has orphan drug staus for ovarian, fallopian tube and peritoneal cancers from the EMA. I believe also from the FDA but I have not checked. Endometrial cancer is likely included in the above, but I have not confirmed. See News Release March 25, 2015.

[Noteable]

https://www.newswire.ca/news-releases/oncolytics-biotech-inc-announces-receipt-of-orphan-drug-designation-from-the-us-fda-for-primary-peritoneal-cancer-517330841.html

[inthno]

As we can all see the orphan drug status was given in 2015 to onc but it is quite obvious that they did not follow up on that so it is a moot point with the exception that it might be able to be used in the bargaining process in regards to a possible buyout. I was told years ago that orphan drug status is nice to have but because of the small number of patients that are involved in these

[Buckhenry]

we dont need to hear anymore reasons why and how much.... we just want to know the date????? but the standard answer is.... just be patient....in other words no body knows jack shot

[Noteable]

"  it is quite obvious that they did not follow up on " Total nonsense!

[Quentin30]

Orphan drug status in the US can be obtained if it is provable that the patient population is less than 200,000. IN the EU it is defined as less than 5 in 10,000. Ultimately ODD means that PDUFA fees are significantly reduced in the US. A current annual fee is of the order of 360k US per annum, per strength. Irrelevant to ONCY as they have no approved product. ODD, enables more frequent

[Noteable]

What I really really mean is that you post rubbish.