G1 Therapeutics Announces Positive Feedback from Trilaciclib End-of-Phase 2 Meeting with FDA; Expects to File NDA in 2020
Based on written feedback from its end-of-Phase 2 meeting with the
“We are pleased with the feedback from our recent meetings with regulatory authorities. We look forward to continuing a collaborative dialogue regarding the marketing applications, as well as discussing further clinical development of trilaciclib,” said Raj Malik, M.D., Chief Medical Officer. “We believe trilaciclib represents an important advance in the care of SCLC patients. We will also move forward with a robust development program to evaluate trilaciclib in multiple tumor types and chemotherapy regimens.”
G1 will request a pre-New Drug Application (NDA) meeting with the
Chemotherapy is an effective and important weapon against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells and kills both, including important stem cells in the bone marrow that produce white blood cells, red blood cells and platelets. This chemotherapy-induced bone marrow damage is known as myelosuppression. When white blood cells, red blood cells and platelets become depleted, chemotherapy patients are at increased risk of infection, experience anemia and fatigue, and are at increased risk of bleeding. Myelosuppression often requires the administration of rescue interventions such as growth factors and blood or platelet transfusions, and may also result in chemotherapy dose delays and reductions.
“In clinical trials, trilaciclib demonstrated the ability to protect bone marrow from chemotherapy damage and meaningfully reduced the need for supportive care interventions, such as G-CSF and transfusions,” said
Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. Trilaciclib is being evaluated in four randomized Phase 2 clinical trials; G1 reported positive results from all these trials in 2018.
G1 is based in
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48 and the timing for next steps with regard to the trilaciclib marketing applications, and are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the Company’s filings with the
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Source: G1 Therapeutics