Post by icemandios on May 19, 2016 23:51:37 GMT
Roche Gets Accelerated Approval for Immunotherapy Drug
Roche Holding RHHBY announced that the FDA has granted accelerated approval to its cancer immunotherapy drug, Tecentriq (atezolizumab), for the treatment of patients suffering from locally advanced or metastatic urothelial carcinoma (mUC), who experienced disease progression during or after platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
Under the accelerated approval program, the FDA grants conditional approval to a drug that fulfills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. However, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Roche is also evaluating Tecentriq in a confirmatory phase III study (IMvigor 211), in comparison to chemotherapy, in patients with bladder cancer who have progressed on at least one prior platinum-containing regimen.
An approval of Tecentriq will further widen Roche’s already broad oncology portfolio.
Additional, the company announced positive results from a phase III study, J-ALEX, on lung cancer drug, Alecensa. Results from a pre-specified interim analysis study showed that Alecensa, an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression free survival, PFS) by 66%, compared to Xalkori, in Japanese patients with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC).
We remind investors that Alecensa was granted accelerated approval by FDA in Dec 2015 for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant to Xalkori.
We expect investors to focus on new drug approvals, as Roche’s top line could be marred by the entry of biosimilars (expected in the second half of 2017 in Europe) for its key drugs like MabThera and Herceptin. On the other hand, new drug approvals, such as those of Cotellic and Alecensa, boosted sales in 2015.
I dunno. Does this mean that kidney failure is not a serious condition? That the lack of an efficacious drug that might address the continuously progressive condition is not "addressing an unmet medical need for a serious condition?" Of course, I am talking about Rayaldee. And I wonder why OPK has apparently not pursued this avenue.
Maybe that's why they hired Trust and (though nobody admits it) Quinn. And maybe it's a little bit like shutting the barn door after the horse has run away.
A good plan is a good plan, but it also requires execution. Perhaps it's just the funk of the market that puts me in a mood, but I find myself finding fault with execution by OPK. Maybe it's just minor details, but minor details have a way of becoming bigger things.
For the want of a nail, the shoe was lost
For the want of a shoe, the horse was lost
For the want of a horse, the rider was lost
For the want of a rider, the message was lost
For the want of a rider, the message was lost
For the want of a message, the battle was lost
For the want of a battle, the war was lost
For the want of a war, the kingdom was lost
Have a nice weekend.
Roche Holding RHHBY announced that the FDA has granted accelerated approval to its cancer immunotherapy drug, Tecentriq (atezolizumab), for the treatment of patients suffering from locally advanced or metastatic urothelial carcinoma (mUC), who experienced disease progression during or after platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
Under the accelerated approval program, the FDA grants conditional approval to a drug that fulfills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. However, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Roche is also evaluating Tecentriq in a confirmatory phase III study (IMvigor 211), in comparison to chemotherapy, in patients with bladder cancer who have progressed on at least one prior platinum-containing regimen.
An approval of Tecentriq will further widen Roche’s already broad oncology portfolio.
Additional, the company announced positive results from a phase III study, J-ALEX, on lung cancer drug, Alecensa. Results from a pre-specified interim analysis study showed that Alecensa, an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression free survival, PFS) by 66%, compared to Xalkori, in Japanese patients with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC).
We remind investors that Alecensa was granted accelerated approval by FDA in Dec 2015 for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant to Xalkori.
We expect investors to focus on new drug approvals, as Roche’s top line could be marred by the entry of biosimilars (expected in the second half of 2017 in Europe) for its key drugs like MabThera and Herceptin. On the other hand, new drug approvals, such as those of Cotellic and Alecensa, boosted sales in 2015.
I dunno. Does this mean that kidney failure is not a serious condition? That the lack of an efficacious drug that might address the continuously progressive condition is not "addressing an unmet medical need for a serious condition?" Of course, I am talking about Rayaldee. And I wonder why OPK has apparently not pursued this avenue.
Maybe that's why they hired Trust and (though nobody admits it) Quinn. And maybe it's a little bit like shutting the barn door after the horse has run away.
A good plan is a good plan, but it also requires execution. Perhaps it's just the funk of the market that puts me in a mood, but I find myself finding fault with execution by OPK. Maybe it's just minor details, but minor details have a way of becoming bigger things.
For the want of a nail, the shoe was lost
For the want of a shoe, the horse was lost
For the want of a horse, the rider was lost
For the want of a rider, the message was lost
For the want of a rider, the message was lost
For the want of a message, the battle was lost
For the want of a battle, the war was lost
For the want of a war, the kingdom was lost
Have a nice weekend.