Lilly cancer drug cleared by FDA for expanded leukemia, lymphoma use

Dive Brief:

• The Food and Drug Administration granted conditional approval to Eli Lilly’s oral cancer drug Jaypirca in two types of blood cancer, expanding its use from a rare type of lymphoma to people with leukemia and lymphoma patients who have previously received two other treatments, the company said Friday.

• Jaypirca is the fourth of a group of drugs called BTK inhibitors, a class that includes AbbVie and Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence. It gained approval earlier this year and posted $42 million in sales through Sept. 30.

• With this approval, Jaypirca can now be used in chronic lymphocytic leukemia or small lymphocytic lymphoma after patients have been treated with AbbVie and Roche’s Venclexta and another BTK inhibitor. Lilly said a Phase 3 trial meant to confirm Jaypirca’s accelerated approval has already met its primary goal.

Dive Insight:

Lilly’s oncology division is sometimes overshadowed by its metabolic medicine and neurology businesses, but cancer drugs were the second biggest contributor to the company’s $25 billion revenue through the first nine months of the year. Long-lived drugs like Alimta and Erbitux still make contributions, but the company is counting on newer drugs like Jaypirca and Retevmo to boost growth.

Both those drugs came via the $8 billion acquisition of Loxo Oncology in 2019, which Lilly undertook to replace revenue as Alimta and Erbitux’s intellectual property protections expired.

The new accelerated approval for Jaypirca was based on a study in 108 leukemia and lymphoma patients whose disease had progressed after a median of five lines of treatment. In the study, Jaypirca reduced or eliminated signs of disease 78 of the patients, and they continued to respond for a median of slightly more than one year.

The trial didn’t compare Jaypirca to a placebo or another type of treatment. A confirmatory trial in patients with chronic and small lymphocytic leukemia who have never been treated with a BTK inhibitor, which compares Jaypirca to a combination of Rituxan and either chemotherapy or Zydelig, has shown Jaypirca can delay disease progression, Lilly said. The data have been shared with the FDA, but aren’t yet under formal review, and will be released at an upcoming medical conference.

Jaypirca is the first “reversible” BTK inhibitor in cancer, an attribute that Lilly claims could help overcome drug resistance in tumor cells.

The first BTK inhibitor, Imbruvica, helped leukemia and lymphoma patients go longer without disease progression than chemotherapy combinations and targeted drugs like Gazyva. But Imbruvica has been steadily losing ground to newer entrants like Calquence, in part because the latter drug is less likely to cause an irregular heartbeat.

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