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The U.S. Food and Drug Administration has granted accelerated approval for daratumumab (Darzalex) for the treatment of patients with heavily pre-treated or double-refractory multiple myeloma who have received at least 3 prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to both.1
FDA Approves Daratumumab for Refractory Multiple Myeloma
“Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.”
Approval is based on findings from 2 open-label studies that evaluated daratumumab in a total of 148 patients. Results showed that 29% of patients in the first study and 36% of patients in the second study achieved an objective response, with responses lasting on average for 7.4 months.
In terms of safety, the most common adverse events associated with daratumumab were infusion-related reactions, fatigue, nausea, back pain, pyrexia, and cough. Treatment with daratumumab may also cause lymphopenia, neutropenia, leukopenia, anemia, and thrombocytopenia.
Clinicians should be aware that daratumumab can interfere with serological testing, which is of importance in patients who require a blood transfusion.
Health care providers should also advise women who may become pregnant to use effective contraception during treatment and for at least 3 months after treatment with daratumumab. Patients who are pregnant should not receive daratumumab.
The recommended dose of daratumumab is 16 mg/kg administered intravenously weekly for 8 weeks, then every 2 weeks for weeks 9 through 24, followed by every 4 weeks from week 25 until disease progression.
Daratumumab is the first human CD38 monoclonal antibody to treat cancer and the first therapeutic antibody approved for the treatment of multiple myeloma.
European biotech gets boost as Genmab market value hits $7 billion
European biotechnology, long a poor relation to the far bigger U.S. industry, got a lift on Tuesday with approval of a new blood cancer drug that promises to bring sustainable profits to the continent’s second-biggest biotech firm.
It’s been a long haul for 16-year-old Genmab but Chief Executive Jan van de Winkel says the Danish company is now on a rapid growth path, with royalties from sales of multiple myeloma drug Darzalex set to fund many new products.
Shares in Genmab, already up 130 percent this year, leapt a further 12 percent on news that the drug, which was licensed to Johnson & Johnson in 2012, had won early U.S. approval, lifting Genmab’s market value to around $7 billion.
That is still below the $16 billion tag on Switzerland’s Actelion, Europe’s biggest biotech, which was founded in 1997. And it is well short of older U.S. groups like Gilead, Amgen, Celgene and Biogen, with values of between $60 billion and $150 billion.
Still, with several analysts forecasting peak annual sales for Darzalex of $5 billion, van de Winkel believes Genmab will start to close the gap on its bigger rivals. He also hopes to find further success in other cancers and multiple sclerosis.
Importantly, a steady cash flow from tiered royalties of between 12 and 20 percent paid by J&J will allow Genmab to retain bigger stakes and hence more commercial upside from its upcoming experimental medicines.
“The income from Darzalex should allow me to hold on to 50 percent or more of our future products because that is what you need to do to build an iconic biotech powerhouse,” van de Winkel said in an interview in London.
The relative weakness of Europe’s biotechnology sector, despite its strong academic science base, has been blamed variously on factors such as lack of entrepreneurial spirit and inadequate funding. But Genmab’s boss believes it is also simply a function of maturity.
“It takes on average 20 years between founding a biotech company and making it sustainably profitable. It took Genentech 22 years and they are arguably the most successful biotech of all time. So we are absolutely on track,” he said.
Total revenues for Europe’s biotech industry were $24 billion last year against $93 billion in the United States, while research spending was under $6 billion against $29 billion, according to consultancy EY.
In contrast to Actelion, which has retained full rights to its medicines for treating a rare condition called pulmonary hypertension, Genmab has struck deals to give away rights to partners in exchange for them funding development.
The approach made sense for a drug like Darzalex, which Genmab could never have afforded to develop on its own, while J&J has devoted hundreds of staff to getting the medicine to market.
Now, with analysts predicting that income from Darzalex will catapult earnings from 2016, van de Winkel plans to keep at least half the rights to new products like Humax-TF-ADC, which is in early clinical trials for various solid tumors.
FDA approves J&J drug for advanced multiple myeloma
U.S. regulators have approved an experimental treatment from Johnson & Johnson that may offer hope to multiple myeloma patients who have run out of other options against the blood cancer.
The U.S. Food and Drug Administration on Monday said it had approved Darzalex (daratumumab) for patients who had already undergone at least three prior standard treatments for the cancer, which affects infection-fighting plasma cells that reside in the bone marrow.
Darzalex, given as an infusion, is a monoclonal antibody that works by helping the immune system attack cancer cells. J&J licensed worldwide rights to the medicine from Danish biotech company Genmab A/S.
In one 106-patient study, tumors shrank or were no longer detectable in 29 percent of patients taking Darzalex, and the benefit lasted for an average of 7.4 months. In a second trial, involving 42 patients, 36 percent of patients taking the J&J/Genmab drug saw a partial or complete reduction in tumors.
Researchers said it is the first antibody drug to demonstrate effectiveness against myeloma without having to be combined with other medicines.
The most common side effects of the treatment included fatigue, nausea, back pain, fever and cough.
An estimated 26,850 Americans are expected to be diagnosed with multiple myeloma in 2015.
All patients eventually become resistant to existing therapies, which include Takeda’s Velcade and Celgene’s Revlimid, as well as newer drugs Kyprolis from Amgen and Celgene’s Pomalyst.
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Labiotech made an amazing infographic showing the most valuable biotechs in Europe. Genmab is in the top 3!
Read more here:
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