G1 Therapeutics’ Cosela (trilaciclib) Earns FDA Oncology Approval
New oncology therapy indicated for use in the treatment of small cell lung cancer
The U.S. Food and Drug Administration (FDA) has approved a new oncology therapy developed by G1 Therapeutics. Cosela (trilaciclib) earned an indication from the FDA to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered before a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).
G1 Therapeutics expects the product to be available to the marketplace in March 2021.
Cosela is a unique and advanced cancer therapy
Cosela is the first and only FDA-approved therapy that helps proactively deliver multilineage myeloprotection to patients with extensive-stage small-cell lung cancer being treated with chemotherapy.
The product is a kinase inhibitor that received Breakthrough Therapy Designation plus Priority Review from the FDA based on positive data it generated in small cell lung cancer patients from three randomized Phase 2 clinical trials.
Cosela is available by prescription only and administered via IV therapy; the product is produced in single-dose vials.
Chemotherapy can have harmful side-effects that Cosela may help prevent in some patients
Chemotherapy drugs are intended to kill cancer cells but may also damage normal, healthy tissues as well. Bone marrow is particularly susceptible to the unintended damaging effects of chemotherapy. The bone marrow produces red blood cells, white blood cells and platelets that are necessary to transport oxygen, fight infection and stop bleeding.
When bone marrow is negatively impacted by chemotherapy, it produces fewer of these cells. This can weaken patients by triggering fatigue, increased risk of infection and bleeding plus significant other healthcare issues. Cosela has successfully demonstrated it may help shield healthy bone marrow cells from the negative side effects of chemotherapy.
G1 Therapeutics is partnering with Boehringer Ingelheim to fully commercialize Cosela and propel its market access
G1 Therapeutics is collaborating with Boehringer Ingelheim to market Cosela in the United States. Boehringer Ingelheim is an ideal partner for G1 Therapeutics to launch Cosela as it is seeking to expand its business presence in the oncology healthcare sector. Cosela’s success at launch and onward will definitely benefit from Boehringer Ingelheim’s market access strategy savvy.
Based in Ingelheim am Rhein, Germany; Boehringer Ingelheim’s U.S. headquarters is located in Ridgefield, Connecticut. The company produced over $23 billion in sales during 2020 and just recently acquired NBE Therapeutics, a company focused on developing new cancer treatment therapies, for $1.5 billion.
For Asian markets, G1 has partnered with Simcere Pharma to sell Cosela in China, Hong Kong, Macau and Taiwan.
G1 Therapeutics has further cancer therapy innovations underway
The company is exploring further uses for Cosela. This includes conducting clinical trials and other evaluations that may lead to bladder, breast and other lung cancer indications. Another pipeline candidate G1 is working on is rintodestrant. This product is intended to be taken orally and is a selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer.
Lerociclib is a G1 Therapeutics product licensed to other biotech companies
G1 Therapeutics has developed a compound intended for use in cancer treatment, Lerociclib (a differentiated oral CDK4/6 inhibitor), that has been licensed to EQRx for the United States, Europe, Japan and other territories; Genor Biopharma has the license for it in the Asia-Pacific region.
These licensing deals have provided G1 Therapeutics with $26 million through initial payments and have the potential to generate approximately $300 million more if Lerociclib is approved by regulators and introduced to global markets.
G1 Therapeutics is a compact and innovative biopharmaceutical enterprise
Founded in 2008, G1 Therapeutics (NASDAQ: GTHX) is based in Research Triangle Park, North Carolina. Its pharmaceutical business model is aligned with the development and commercialization of new small molecule therapies for use in oncology. Congratulations to G1 Therapeutics on the launch of their first new oncology therapy Cosela!
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