J&J’s Imbruvica bags tenth FDA nod; BMS withdraws application for lung cancer drugs

By PharmaCompass

2019-01-31

Impressions: 115 Article

Last week, we reported on how AbbVie and Johnson & Johnson’s blockbuster Imbruvica, in combination with two chemo drugs, failed to top the chemo duo alone in a Phase 3 study of previously untreated pancreatic cancer patients whose disease had metastasized.

After last week’s setback, Imbruvica won FDA approval as the first non-chemotherapy treatment for untreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the tenth approval for Imbruvica since its launch in 2013, and the drug generated sales of about US$ 2.6 billion last year.

The drug has secured the FDA nod in combination with Roche’s obinutuzumab in adults with CLL/SLL. The approval expands the use of Imbruvica in frontline CLL/SLL beyond its use as a monotherapy.

Meanwhile, Bristol-Myers Squibb (BMS) has voluntarily withdrawn an FDA application for a combo lung cancer treatment. The drugs — ipilimumab (brand name Yervoy) and nivolumab (Opdivo) — belong to a class called checkpoint inhibitors. BMS said it pulled its applications after recent discussions with the USFDA.

BMS, which announced a planned US$ 74 billion acquisition of cancer drug maker Celgene earlier this month, is still pursuing approval for the Yervoy-Opdivo combination for use by lung cancer patients with a different biomarker. Such usage is being tested in a separate part of the study.

Meanwhile, Eli Lilly faced yet another setback. A week after Eli Lilly reported disappointing findings for its cancer drug Lartruvo, the FDA is discouraging new patients from getting started on the medicine and urging those already on it to consult with their doctors. A similar announcement has been made by the EMA.

Lartruvo had won an accelerated FDA approval in 2016 as part of a combo with the chemotherapy doxorubicin". It was to be a first-line treatment for a subset of patients with soft tissue sarcoma, which had seen no new approvals in decades. By the third quarter of 2018, Lilly had raked in US$ 221.2 million in Lartruvo sales.

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