Phase 3 Study of BLINCYTO® (Blinatumomab) Met Primary Endpoint Of Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia. Study Stopped Early for Efficacy.
"The FDA's breakthrough therapy designation and accelerated approval of BLINCYTO underscore the dire prognosis for these patients. This is the first study to demonstrate an overall survival benefit for these patients with an immunotherapy, and this is a tremendously rare achievement in relapsed and refractory ALL," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
Seems like a new competitor of Marqibo will reach the market soon.
For US: 2000 N-Ras metastatic melanoma patients/year, duration of treatment with Binimetinib (PFS) is 3 months, price for GSK or Roche MEK inhibitors is ~$8,000/month.
$8000 X 3 X 2000 = $48M.
"anyone care to differ on these sales projections?"
Why don't you listen the last earning call? NRas melanoma market in US is $60M, in Europe it is another $100M.
"That's when a PR is most warranted." It is not how it worked before. They issued PR for NDA submission of Beleodaq on Dec 20, 2013 and for NDA acceptance on Feb 6, 2014. Same with Evomela, PRs both for NDA submission on Dec 26, 2014 and for NDA acceptance on Feb 6, 2015. In case of Apaziquone development, they want to keep it low profile.
Interestingly, they did not mention Apaziquone NDA in their 2015 accomplishments. They also did not announce it in December, only issued 8-K. Why keep it secret?
was recently published: "Panoptic clinical review of the current and future treatment of relapsed/refractory T-cell lymphomas: Peripheral T-cell lymphomas"
Some interesting facts:
1. Current data indicates that Folotyn should not be used to treat AITL (at least until further studies are conducted) due to lack of efficacy (I didn't know that), Beleodaq may be particularly active in AITL (an observation that requires confirmation),and Istodax may not be as active in patients with the rarest PTCL subtypes.
2. Fourth drug, Adcetris, was designed to treat specifically sALCL (12% of PTCL patients). Treatment with Adcetris was associated with an 86% ORR, with 57% of sALCL patients achieving a CR. Interestingly, that retreatment with single-agent Adcetris (following relapse after achieving a CR or PR during prior Adcetris therapy) can also result in high response rates in sALCL patients (ORR 88%, CR rate 63%) similar to those seen during initial treatment.
Therefore, Adcetris really took almost entire sALCL market from other drugs, even after relapse.
Spectrum will be informed within 60 days whether NDA is accepted or rejected. However, PDUFA date will appear only in 74-day letter. Some companies announce NDA acceptance earlier and inform about PDUFA date later.
Beleodaq poor performance could be related to insurance issues.
From Blue Shield of California Medicare Part D Coverage Criteria (Updated 01/2016):
1) Relapsed or refractory peripheral T-cell Lymphoma:
• Disease progression on or intolerance to, at least one previous chemotherapy regimen supported in published literature, AND
• Disease progression, intolerance, or contraindication to Istodax (romidepsin), AND
• Dose is 1000mg/m2 IV daily on days 1 to 5 of a 21-day cycle.
It seems like, first choice for treatment is Istodax.
I think, competition is not a big issue here. Problem is that vast majority of urologists in U.S. don't use any post-TURBT instillations. It is described in the article "National Practice Patterns for Immediate Postoperative Instillation of Chemotherapy in Nonmuscle Invasive Bladder Cancer". According to the study only 16.9% of patients receive intravesical postoperative chemotherapy. Of the urologists surveyed 66% never used intravesical postoperative chemotherapy, 13% rarely used it, 17% used it half of the time and only 2% used it all of the time. "Their practice pattern is consistent with the AUA guideline for the management of NMIBC since intravesical postoperative chemotherapy is listed as an option for the treatment of patients with primary low grade tumors." Option, not recommendation or requirement. To sell Apaziquone, FDA and Spectrum need to change AUA guideline. They also need a strong marketing effort. Allergan involvement would be helpful.
Something is wrong with your calculations. If a change from 30% to 15% (historical data) is a reduction by 50%, then a change from 50% to 28% (30-90 min sub-population) is a reduction by 44%.
Yes, it is a crowded space. However, with a drug acting by a new mechanism, you can combine it with already approved drugs to make, for example, Kyprolis+Filanesb combo, or use it as a single agent in the next line of treatment, for instance, after Kyprolis failure. Both scenarios were considered by Array for Filanesib development.