Ua hoʻolaha ʻo Mirati Therapeutics, Inc., kahi hui oncology i hoʻopaʻa ʻia i kēia lā ua ʻae ka US Food and Drug Administration (FDA) i ka New Drug Application (NDA) no ka adagrasib no ka mālama ʻana i nā poʻe maʻi me ka maʻi maʻi ʻaʻai liʻiliʻi liʻiliʻi (NSCLC) e mālama ana i ka hoʻololi ʻana o KRASG12C i loaʻa ma ka liʻiliʻi o hoʻokahi lāʻau lapaʻau systemic mua. ʻO ka lā ʻo Prescription Drug User Fee Action (PDUFA) no adagrasib ʻo Dekemaba 14, 2022.

Ke nānā ʻia nei ka adagrasib NDA e ka FDA for Accelerated Approval (Subpart H), ka mea e ʻae ai i ka ʻae ʻana i nā lāʻau lapaʻau e mālama i nā kūlana koʻikoʻi, a e hoʻopiha i kahi pono olakino i hoʻokumu ʻia ma kahi hope hope. Eia kekahi, ke nānā ʻia nei ka noi ma lalo o ka papahana hoʻokele FDA Real-Time Oncology Review (RTOR), e manaʻo nei e ʻimi i kahi kaʻina loiloi ʻoi aku ka maikaʻi e hōʻoia i ka loaʻa ʻana o nā lapaʻau palekana a maikaʻi i nā poʻe maʻi i ka hiki wawe. Ua loaʻa pū ʻo Adagrasib i ka Breakthrough Therapy Designation ma US ma ke ʻano he lāʻau lapaʻau kūpono no nā poʻe maʻi me ka NSCLC e hoʻopaʻa ana i ka mutation KRASG12C i loaʻa ma ka liʻiliʻi ma mua o hoʻokahi lāʻau ʻōnaehana.

ʻO Pasi A. Jänne, MD, Ph.D., he mea noiʻi e komo ana i ka noiʻi KRYSTAL-1, a me ka luna o ka Lowe Center for Thoracic Oncology ma Dana-Farber Cancer Institute, i ʻōlelo ʻia, "KRAS mutations have been nottoriously hard to target and i ka mōʻaukala ua loaʻa nā koho therapeutic palena. Hoʻopili ʻia ka biomarker KRAG12C me nā hopena ola maikaʻi ʻole. ʻO ka loiloi a ka FDA o ka adagrasib NDA e hōʻailona ana i ka holomua nui i ka hāʻawi ʻana i kahi koho hou i koho ʻia no ka poʻe e noho ana me ka maʻi maʻi maʻi maʻi ʻaʻole liʻiliʻi ʻo KRASG12C.

"ʻO ka ʻae ʻia ʻana o kā mākou NDA no adagrasib kahi hana nui i mua o ka hoʻomau ʻana o Mirati e holomua i nā koho lapaʻau hou, ʻokoʻa no nā poʻe maʻi me nā maʻi maʻi KRASG12C," wahi a Charles Baum, MD, Ph.D., pelekikena, hoʻokumu a me ke poʻo o ka noiʻi. hoʻomohala, Mirati Therapeutics, Inc. "Ke kakali nei mākou i ka hana pū me ka FDA i kā lākou loiloi ʻana i kā mākou noi a hiki ke hāʻawi i kahi koho hou no nā poʻe maʻi me ka maʻi maʻi ʻaʻai liʻiliʻi liʻiliʻi."

Hoʻokumu ʻia ka NDA ma ka Phase 2 hoʻopaʻa inoa-ʻae cohort o ka KRYSTAL-1 study, e loiloi ana i ka adagrasib 600mg BID i nā mea maʻi me ka NSCLC kiʻekiʻe e mālama ana i ka mutation KRASG12C ma hope o ka mālama mua ʻana me ka immunotherapy a me ka chemotherapy, i hui pū ʻia a i ʻole. Ua hōʻike ka Hui i ka ʻikepili topline maikaʻi mai kēia cohort i Kepakemapa 2021, a hoʻolālā e hōʻike i nā hopena kikoʻī i kahi hālāwai olakino i ka hapa mua o 2022.

Ke hoʻomau nei ka Hui i kahi hoʻokolohua Phase 3, KRYSTAL-12, e loiloi ana i ka adagrasib versus docetaxel i nā mea maʻi me ka laina lua KRASG12C-mutated NSCLC.

He aha e lawe ʻia mai kēia ʻatikala:

The NDA is based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating adagrasib 600mg BID in patients with advanced NSCLC harboring the KRASG12C mutation following prior treatment with immunotherapy and chemotherapy, either together or sequentially.
Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy.
The adagrasib NDA is being reviewed by the FDA for Accelerated Approval (Subpart H), which allows for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.