FDA News

FDA expands Sprycel approval to include certain children with acute lymphoblastic leukemia

The FDA expanded the approval of dasatinib tablets to include its use with chemotherapy for children aged 1 year or older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

Dasatinib (Sprycel, Bristol-Myers Squibb) — a second-generation tyrosine kinase inhibitor — previously received priority review from the FDA for this indication.

The agent already had been approved for adults with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase; adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML who were resistant to or intolerant of prior therapy, including imatinib; adults with Ph+ ALL who were resistant to or intolerant of prior therapy; and children with Ph+ CML in chronic phase.

“We recognize the urgency around developing and delivering therapies for children and young adults living with cancer, and [this] approval is an important example of our commitment to pediatric oncology,” Jeffrey Jackson, PhD, development lead for hematology at Bristol-Myers Squibb, said in a company-issued press release. “Building on our previous indication for children with Ph+ [CML] in chronic phase, we’re pleased to bring Sprycel tablets to a second type of pediatric leukemia. This approval will give physicians another treatment option to offer appropriate pediatric patients with Ph+ ALL.”

The FDA based the new approval on results of the phase 2, multicenter, single-arm CA180-372 study.

The efficacy analysis include 78 children with newly diagnosed B-cell precursor Ph+ ALL. All patients received dasatinib tablets with chemotherapy.

Researchers reported a 3-year EFS rate of 64.1% (95% CI, 52.4-74.1).

A safety analysis included 81 patients. Three patients experienced fatal adverse reactions. Eight patients experienced adverse reactions that led to treatment discontinuation. These events included fungal sepsis, hepatotoxicity of graft-versus-host disease, thrombocytopenia, cytomegalovirus infection, pneumonia, nausea, enteritis and drug hypersensitivity.

The most common serious adverse reactions included pyrexia, febrile neutropenia, mucositis, diarrhea, sepsis, hypotension, infections, hypersensitivity, vomiting, renal insufficiency, abdominal pain and musculoskeletal pain.

“As treatments have advanced in recent years, we’ve seen improvements in outcomes for pediatric patients with Ph+ ALL overall, but there remains a need for additional options,” researcher Stephen Hunger, MD, chief of the division of oncology and director of the Center for Childhood Cancer Research at Children’s Hospital of Philadelphia, said in the release. “[The trial] was particularly informative because it was designed to limit the use of cranial irradiation and stem cell transplant. ... These results show that Sprycel is an effective medication for physicians to consider for children and adolescents with Ph+ ALL.”

The FDA expanded the approval of dasatinib tablets to include its use with chemotherapy for children aged 1 year or older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

Dasatinib (Sprycel, Bristol-Myers Squibb) — a second-generation tyrosine kinase inhibitor — previously received priority review from the FDA for this indication.

The agent already had been approved for adults with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase; adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML who were resistant to or intolerant of prior therapy, including imatinib; adults with Ph+ ALL who were resistant to or intolerant of prior therapy; and children with Ph+ CML in chronic phase.

“We recognize the urgency around developing and delivering therapies for children and young adults living with cancer, and [this] approval is an important example of our commitment to pediatric oncology,” Jeffrey Jackson, PhD, development lead for hematology at Bristol-Myers Squibb, said in a company-issued press release. “Building on our previous indication for children with Ph+ [CML] in chronic phase, we’re pleased to bring Sprycel tablets to a second type of pediatric leukemia. This approval will give physicians another treatment option to offer appropriate pediatric patients with Ph+ ALL.”

The FDA based the new approval on results of the phase 2, multicenter, single-arm CA180-372 study.

The efficacy analysis include 78 children with newly diagnosed B-cell precursor Ph+ ALL. All patients received dasatinib tablets with chemotherapy.

Researchers reported a 3-year EFS rate of 64.1% (95% CI, 52.4-74.1).

A safety analysis included 81 patients. Three patients experienced fatal adverse reactions. Eight patients experienced adverse reactions that led to treatment discontinuation. These events included fungal sepsis, hepatotoxicity of graft-versus-host disease, thrombocytopenia, cytomegalovirus infection, pneumonia, nausea, enteritis and drug hypersensitivity.

The most common serious adverse reactions included pyrexia, febrile neutropenia, mucositis, diarrhea, sepsis, hypotension, infections, hypersensitivity, vomiting, renal insufficiency, abdominal pain and musculoskeletal pain.

“As treatments have advanced in recent years, we’ve seen improvements in outcomes for pediatric patients with Ph+ ALL overall, but there remains a need for additional options,” researcher Stephen Hunger, MD, chief of the division of oncology and director of the Center for Childhood Cancer Research at Children’s Hospital of Philadelphia, said in the release. “[The trial] was particularly informative because it was designed to limit the use of cranial irradiation and stem cell transplant. ... These results show that Sprycel is an effective medication for physicians to consider for children and adolescents with Ph+ ALL.”

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