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FDA Approves; AZ nabs; Nordisk settles; Novartis pays

May 02, 2017

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FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer

Takeda Pharmaceuticals announced the FDA approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Brigatinib is a kinase inhibitor that can be taken orally. The recommended dose is 90 mg orally once daily for the first 7 days. If 90 mg is tolerated during the first 7 days, the patient should increase the dose to 180 mg orally once daily. The pill can be taken with or without food. Brigatinib has an orphan drug designation for this indication and Takeda received an Accelerated Approval of the drug based on tumor response rate and duration of response. An Accelerated Approval means Takeda can market the drug now but additional studies (i.e., a phase 3 clinical trial) may be needed by the FDA moving forward.

AZ nabs FDA nod for bladder cancer for checkpoint med Imfinzi

AstraZeneca got its first FDA approval with its checkpoint inhibitor Imfinzi (durvalumab), as the British pharma giant picked up an accelerated green light in urothelial carcinoma. This makes the company the third Big Pharma player to enter the advanced bladder cancer space with a PD-1/PD-L1 inhibitor. Imfinzi will take on established player Tecentriq from Roche, which hit the scene last May, and Opdivo, the Bristol-Myers Squibb entrant that won its bladder go-ahead in February. Merck is still chasing a bladder cancer nod for its contender, Keytruda. Imfinzi, though, will roll out at a higher price point than its nemeses; as estimated average monthly cost of the med will be $15,000, compared with its rivals’ $12,500. The approval comes based on a single-arm, 182-patient trial, which produced an overall response rate of 26.3% among the 95 patients with high PD-L1 scores. As Tecentriq does, Imfinzi goes hand in hand with a complementary diagnostic from Ventana that assesses PD-L1 levels in tumors.

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Novo Nordisk to settle med-whistleblower suit

Novo Nordisk has moved to settle a whistleblower lawsuit alleging the company ran a “white-coat marketing scheme” to pump up sales of NovoLog, Victoza and Levemir. According to the suit, recently unsealed as part of the settlement process—Novo Nordisk partnered with a clinical education company, Healthstar’s PT, to set up a program dubbed Changing Life with Diabetes. The group hired and trained certified diabetes educators (CDEs), according to the suit, which was brought by two former managers and more than two dozen states. The whistleblowers claim that since 2006, Novo ran the program to gain crucial access to physician practices, where CDEs would provide thousands of dollars’ worth of educational programs and materials. The idea behind the program, according to the suit, was to induce prescribers to write scripts for Novo’s diabetes meds by offering such services. Due to this, U.S. pricing pressures have taken a toll at Novo lately, forcing the company to cast off 1,000 staffers last fall.

Novartis to pay $50M, lose some drug coverage in Korean bribery probe

For more than a year, Novartis has been under investigation in Korea for allegedly bribing doctors to pump up sales. Now, the Swiss drug giant is learning about its punishment in the country as authorities there decided to issue a fine of nearly $50 million. On a preliminary basis, Korea’s Ministry of Health & Welfare (MHW) has fined Novartis 55 billion Korean won, approximately $50 million, and suspended reimbursement of Exelon and Zometa for three months. The final decision is expected by the end of May. Previously, authorities were weighing a suspension of the company’s big-selling cancer med Glivec, according to The Korea Times, but feared that move would leave some 3,000 to 5,000 chronic myeloid leukemia patients with no other options.