Sprycel (dasatinib) is a kinase inhibitor developed by Bristol-Myers Squibb for the treatment of chronic myeloid leukemia (CML) and some other cancers. The drug was approved by the US Food and Drug Administration in 2006 for the treatment of adults with CML in chronic, accelerated or myeloid or lymphoid blast phase and for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Sprycel was the second kinase inhibitor approved for the treatment of CML after Novartis' Gleevec (imatinib), which was approved in 2001 and revolutionized CML treatment.

Sprycel was developed through extensive research to overcome resistance to imatinib. Extensive preclinical and clinical studies showed that Sprycel is able to inhibit a broader range of BCR-ABL kinase mutations that confer resistance to imatinib. This dual inhibition allows Sprycel to effectively treat CML patients who become resistant to or cannot tolerate imatinib. Sprycel received priority review from the FDA based on clinical trial results showing superior response rates compared to high-dose imatinib in resistant or intolerant CML patients.

Commercial Performance and Market Share

Since its launch in 2006, Sprycel has achieved strong commercial success and emerged as a leading treatment for CML, both as a first-line therapy and for resistant or intolerant patients. In the US market, Sprycel generated sales of $1.2 billion in 2020, a 4% year-over-year growth. Globally, Sprycel sales totaled $2.3 billion last year.

Sprycel captured more than 30% share of the global CML drug market within five years of launch. While imatinib still leads the CML market, Sprycel has consistently gained market share in recent years, especially in the frontline setting. A 2018 market report showed Sprycel captured a 34% value share of the $4 billion CML market worldwide. Its sales exceeded imatinib sales for the first time that year.

Sustained growth has been driven by expanded indications in earlier lines of therapy. Sprycel was approved for frontline treatment of newly diagnosed chronic phase CML in 2010 based on phase 3 clinical trial results showing superior efficacy compared to imatinib. This expanded its addressable market beyond resistant/intolerant patients. Usage has also increased over time based on its differentiation as a highly effective oncedaily therapy compared to the burdens of daily dosing with imatinib.

Increased Competition and Biosimilar Threats

While Sprycel has strengthened its leadership position in CML treatment, competition has increased over the past decade. In 2012, Gleevec lost patent protection, leading to approvals of several generic imatinib products which lowered prices and regained share losses for imatinib. Novartis also launched Tasigna (nilotinib), which achieved similar efficacy to Sprycel and captured 15-20% share.

The expiration of Sprycel patents starting 2021 poses a major risk to its market performance. In 2019, Pfizer received FDA approval for its dasatinib biosimilar. Other dasatinib biosimilars from companies like Aurobindo and Mylan are expected to be approved soon. Biosimilar competition has caused price erosion and market share losses for many originator biologics. With multiple generic and biosimilar options available at lower costs, Sprycel's leadership position could be at risk without a differentiated strategy.

Research and Pipeline Opportunities

To combat competition, Bristol-Myers Squibb is pursuing expanded indications, new combinations therapies and next-generation treatments in oncology research. For CML specifically, the company is exploring multiple clinical trials combining Sprycel with other agents for optimal efficacy and further differentiation. One large Phase 3 trial is evaluating the combination of Sprycel and corticosteroids for newly diagnosed chronic phase CML patients.

Beyond CML, dasatinib is being studied in several other hematological cancers and solid tumors based on its multi-kinase inhibition profile. Positive Phase 2 results were reported from a trial combining dasatinib with chemotherapy for relapsed/refractory acute myeloid leukemia. Dasatinib is also in late-stage development for prostate and lung cancers in combination with other drugs.

While near-term generic competition poses challenges, Bristol-Myers Squibb's extensive research efforts aim to maximize the clinical utility and commercial potential of dasatinib over the long run. Expanded pipeline opportunities could help offset declining revenues from CML and ensure Sprycel maintains an important role in the future of cancer treatment.