Genentech's immunotherapy Tecentriq has won an accelerated US Food and Drug Administration approval for a specific type of bladder cancer.
The drug has been cleared to treat locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery or after surgery.
Around 76,000 Americans are diagnosed with bladder cancer every year. mUC accounts for 90 percent of all cases and can also be found in the renal pelvis, ureter and urethral. FDA approval of Tecentriq (atezolizumab) gives these patients the first new licensed treatment option in more than 30 years.
The drug's accelerated clearance is based on tumour response rate and duration of response seen in Phase II IMvigor 210 clinical trial. This showed an overall objective response rate of 14.8 percent, 9.5 percent in patients with PD-L1 expression under 5 percent and 26 percent in those with PD-L1 expression greater than 5 percent.
However, this benefit may need to be verified in confirmatory trials for a switch to a full regulatory green light.
The most common grade 3-4 adverse reactions included urinary tract infection (9 percent); anaemia (8 percent); fatigue (6 percent); dyspnea (difficulty breathing; 4 percent); and abdominal pain (4 percent). In the trial, three people (0.9 percent) experienced either sepsis, pneumonitis (lung problems) or intestinal obstruction, which led to death.
The Roche group noted that the drug should be available to patients in the US within one to two weeks.