Clinical applications for CDK 4/6 inhibitors introduced by Syngenta Pharmaceuticals for $170 million were accepted

Screenshot source: CDE official website cell cycle protein-dependent kinases 4 and 6 (CDK 4/6) are considered to be the key regulatory factors driving cell division.
CDK4/6 By binding to a class of proteins called cyclin D, the phosphorylated retinal cytoblastoma gene (Rb) releases the transcription factor E2F, which in turn promotes the transcription of genes associated with the cell cycle, allowing the cell cycle to enter the DNA replication period (S1 phase) from the pre-DNA synthesis stage (G1 stage).
Trilaciclib is a short-acting CDK4/6 inhibitor that reduces the replication burden of bone marrow hematopoietic stem cells through a short G1 phase block, thus reducing the depletion of bone marrow hematopoietic stem cells.
, one of the great side effects of chemotherapy is bone marrow inhibition, where blood cell pregeneration activity decreases.
Trilaciclib is expected to protect hematopoietic stem cells, pregeneral cells and the immune system during chemotherapy.
the chemical structure of trilaciclib hydrochloric acid (Photo: medchemexpress.cn) In August, the FDA accepted a new drug application (NDA) from trilaciclib for patients with small cell lung cancer (SCLC) who are undergoing chemotherapy treatment.
fda also granted it priority review eligibility and is expected to respond by February 15 next year.
noted that the product has previously been recognized as a breakthrough therapy for SCLC, which was awarded by the FDA.
there are clinical experts comment that due to bone marrow toxicity, chemotherapy drugs in the treatment of SCLC can not play a role in the most vivid, trilaciclib's unique bone marrow protection function, for chemotherapy in the initial treatment and recurrence of SCLC treatment escort.
in Phase 2 clinical trials, trilaciclib achieved a series of positive results.
studies have shown that treatment with trilaciclib protects the bone marrow and immune system from chemotherapy drugs, protects patients from side effects of bone marrow inhibition, in some cases may help patients live longer, and can be included in a variety of chemotherapy options, including I/O plus chemotherapy.
Results from phase 2 clinical trials (Photo: Reference: References) In clinical trials for small cell lung cancer, trilaciclib significantly improved the patient experience, in particular by reducing fatigue and reducing the use of granulocyte set stimulation factors (G-CSF) and blood transfusions.
in another randomized trial of metastasis triple-negative breast cancer patients, trilaciclib significantly improved the overall survival (OS) of patients when used in combination with chemotherapy.
addition, G1 Therapeutics plans to launch a Phase 3 registered clinical trial for colorectal cancer in the United States in the fourth quarter of 2020.
According to an earlier press release from G1 Therapeutics, there is currently no effective treatment to protect patients from the toxic effects of chemotherapy, and if trilaciclib is approved, it will be the first preventive bone marrow retention therapy to make chemotherapy safer and reduce the need for emergency treatments such as growth factor infusions and blood transfusions.
Trilaciclib significantly improves the post-chemotherapy treatment experience in SCLC patients (Photo: Source: Supplied) There are many targeted therapies and immunotherapies that have been clinically available and have shown good results in treating a wide range of cancers.
but there is no denying that chemotherapy remains the cornerstone of cancer treatment.
of the most common side effects of chemotherapy is bone marrow suppression.
is due to the serious consequences of bone marrow stem cells being affected by chemotherapy drugs, resulting in anemia, neotylacellular reduction, or plate plate reduction.
toxic side effects have a wide range of effects on the patient's treatment experience and prognostics.
the emergence of Trilaciclib has the potential to benefit many cancer patients.
role is to protect bone marrow and immune system function during chemotherapy and improve patient prognostication.
The submission and acceptance of clinical applications by the synth pharmaceutical industry in China is another progress in the research and development process of this new drug: 1. The Drug Review Center (CDE) of the State Drug Administration of China. Retrieved May 29, 2019, from s.2. Professor Cheng Ying: Trilaciclib , the "guardian" of chemotherapy. Retrieved August 17, 2020, from [3]G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer. Retrieved August 17, 2020, from [4]G1 Corporate Presentation. Retrieved August 17, 2020, from sonic pharmaceuticals and G1 Therapeutics announced the signing of an exclusive license agreement for Trilaciclib products in Greater China. Retrieved Aug 03, 2020, from Source: Medical Mission Hills