Replies to post #752881 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

It is at moments such as these, that it is good and salutary to remember that DCVax-l is perhaps the safest biotherapeutic cancer therapy, with a known mechanism of action that directs t-cell intra-tumoral infiltration — (beyond the blood-brain barrier) targeting (in coordination with other immune communications/activities) an incredibly broad spectrum of relevant cancer cells leading to increases in long term survival for a significant number of patients, and this was already followed by the MHRA for over ten years during their compassionate program observance.

(The three recently approved therapies likely took longer due to safety concerns, or proof of safety verification.)

[Lykiri]

This new medicine had an extremely long duration from 1st CHM meeting to approval – 378 days, which is the second longest in my dataset (just beating out mRESVIA (371), which was approved last week, and just behind Sugemalimab (398), the longest in the set).

tunnelvisionofplenty,
I think it's more like 224 days between the first CHMP meeting and the approval today.

SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 25TH JULY and FRIDAY 26TH JULY 2024

The Commission considered and advised on medicines used with another cancer medicine to
treat adults with lung cancer called non-small cell lung cancer when the cancer has spread to
other parts of the body and has gone through certain gene changes.

https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1722468014372

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 6 March 2025, approved lazertinib (brand name Lazcluze) for adults with non-small cell lung cancer that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). It is to be used in combination with an approved cancer medicine called amivantamab

.
https://www.gov.uk/government/news/lazertinib-approved-for-use-in-combination-with-amivantamab-for-the-treatment-of-adults-with-non-small-cell-lung-cancer?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=38e7cbd1-9503-4735-8318-3d76dbcde455&utm_content=immediately

NOTE: SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 21ST AND FRIDAY 22ND NOVEMBER 2024 published today.
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1795506843637