FDA expedites two GlaxoSmithKline treatments

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GlaxoSmithKline book-ended the weekend with two items of note: Friday's announcement that the FDA bestowed a breakthrough-therapy designation for the GSK-Genmab drug Arzerra for untreated chronic lymphocytic leukemia (CLL), and Monday's announcement that it grabbed priority review status for its sNDA to combine Tafinlar (dabrafenib) and Mekinist (trametinib) for unresectable metastatic melanoma with a BRAF V600 E or K mutation.

The infusion medication Arzerra is currently approved for patients who have already been treated, and either failed to respond to fludarabine and alemtuzumab or were treated with these medications, but experienced a relapse after six months.

Friday's CLL breakthrough therapy designation adds some heat to an already active segment. It marks not only GSK's second designation for 2013, but also puts the drug in a competitive scrum that includes Janssen/Pharmacyclics ibrutinib, which has three breakthrough designations to its name (one each for CLL/SLL, relapsed/refractory mantle cell myeloma, and Waldenstrom's macroglobulinemia), and Roche's GA101 (obinutuzumab), which also has a breakthrough therapy designation and priority review status.

Janssen's entry is a variation of GSK's approach—whereas Glaxo is looking for an expanded indication, Janssen is seeking second-line status, for patients who have failed on other therapies. Roche's Phase III contender seeks the same space—previously untreated CLL patients—by combining GA101 with chlorambucil, a mix which studies indicate was superior to mixing MabThera/Rituxan and chlorambucil. Part of Roche's motivation: Rituxan's patent protection is set to expire in two years.

Glaxo's Monday Tafinlar-Mekinist announcement puts the combo drug in line for FDA review in early 2014. The companies sent the same combination for European regulatory review in February 2013. Each of the two drugs was sanctioned for use as a single-agent oral therapy in treating unresectable or metastatic melanoma in May.

The backdrop for the announcements was a dim one—the Institutes of Medicine released a negative assessment of the state of cancer care just days before, saying that care for all types of cancer is falling short. Among the problems identified by the non-profit were that patient communication is lacking and that “65% to 80% of cancer patients with poor prognoses incorrectly believed their treatment could result in care,” a likely shortage of oncology-trained HCPs to meet rising demand, and a high number of treatments that are not evidence-based due to the complexity of the disease, among other factors.

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