All-oral Inqovi-Venclexta regimen also OK'd for older patients with this leukemia
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The U.S. Food and Drug Administration (FDA) has approved a new combination therapy — Inqovi (decitabine and cedazuridine) plus Venclexta (venetoclax) — to treat adults with newly diagnosed acute myeloid leukemia (AML) who are 75 or older or are not eligible for intensive first-line chemotherapy.
Inqovi and Venclexta are both oral medications approved in the U.S. for treating cancer, and this decision makes the combo the first all-oral regimen to win FDA approval for this indication, according to Inqovi’s maker Taiho Oncology.
“This FDA approval represents a significant milestone for patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive induction chemotherapy,” Peter Melnyk, president and CEO of Taiho Oncology, said in a company press release. The company is a subsidiary of Taiho Pharmaceutical.
“With the approval of an all-oral regimen, Inqovi in combination with [Venclexta] brings a new treatment option to this patient population,” Melnyk said, adding that the FDA decision “underscores our commitment to advancing innovative, patient-focused therapies in hematologic malignancies.”
AML is a form of blood cancer. According to the American Cancer Society, more than 20,000 people in the U.S. are expected to be diagnosed with this form of leukemia this year.
Intensive chemotherapies are a standard first-line treatment, but, according to Taiho Oncology, more than half of those with the disease are not eligible for such intensive treatment. This is typically due to factors like older age or other co-occurring health problems.
“As a leader in the development of oral anti-cancer regimens, we are proud that Inqovi in combination with [Venclexta] will now be available for newly diagnosed patients with acute myeloid leukemia in the U.S.,” said Harold Keer, MD, PhD, chief medical officer of Taiho Oncology.
Both parts of combo AML therapy already approved for US use
Inqovi works by inhibiting cancer cells’ ability to synthesize DNA; Venclexta blocks a protein that promotes cancer cell survival. Both therapies were already FDA-approved for other forms of blood cancer.
The new FDA approval of the all-oral regimen for chemo-ineligible AML patients was based mainly on data from the Phase 2b ASCERTAIN-V (NCT04657081) study, which involved more than 100 adults with newly diagnosed AML who were not eligible for intensive chemotherapy.
The results showed that 42% of participants given Inqovi plus venetoclax achieved a complete response, meaning their blood counts returned to normal and signs of leukemia were cleared from the bone marrow. The median time from starting treatment to achieving a complete response was two months, and, as of the latest follow-up, most patients who achieved a complete response had no recurrence of cancer, the company noted.
This approval marks an important step forward in expanding how treatment can be delivered for this patient population, offering an all‑oral option that can potentially reduce the overall treatment burden associated with receiving treatment in hospitals or infusion centers.
According to Inqovi’s prescribing information, the most common side effects of the newly authorized combo regimen include low blood cell counts, infection, diarrhea, nausea, and constipation. Fatigue, shortness of breath, decreased appetite, rash, and pain in the joints, muscles, and/or abdomen also were common.
The combination therapy can also cause severe myelosuppression, a condition in which the body cannot make enough new blood cells, which can be fatal. It also may cause damage to a developing fetus if used during pregnancy.
“This approval marks an important step forward in expanding how treatment can be delivered for this patient population, offering an all‑oral option that can potentially reduce the overall treatment burden associated with receiving treatment in hospitals or infusion centers,” Keer said. “We believe this approach has the potential to make a meaningful impact for patients and caregivers.”
