Counterfeit Avastin hits U.S. shores, Genentech warns

Counterfeit Avastin — the world’s best-selling cancer drug — is being distributed in the United States, Genentech Inc. and parent company Roche warned Tuesday.
Officials from South San Francisco-based Genentech could not say if patients had been directly harmed by counterfeit Avastin, which has been sold at least since December, or how much revenue the company had lost. But a Roche evaluation of the counterfeit vials showed that they did not contain the active ingredient in Avastin.

FDA revokes Avastin OK for breast cancer

The Food and Drug Administration revoked approval for Genentech Inc.'s breast cancer drug Avastin, the agency said Friday.
In a statement, FDA Commissioner Margaret Hamburg said she is revoking the agency's approval of Avastin, also known as bevacizumab, after concluding the drug was not safe and effective in combatting metastatic breast cancer.
Avastin will remain on the market for types of colon, lung, kidney and brain cancer.

New label on Genentech's Avastin warns of infertility

The world’s best-selling cancer drug, Genentech Inc.’s Avastin, now carries a warning about increased risk of infertility in premenopausal women.
The Food and Drug Administration said Avastin’s label as of Sept. 30 includes the new warning regarding “ovarian failure.” Data suggest that some women with the potential of bearing children may become infertile as a result of Avastin and should talk to their doctor before starting treatment, the FDA said.

Blue Shield of California to stop Avastin coverage for breast cancer

Blue Shield of California will stop paying for the use of Avastin in treating breast cancer, the New York Times reports.
A federal advisory committee in June recommended the Food and Drug Administration rescind Avastin’s approval for the treatment of breast cancer.

FDA: Repackaged Avastin blinds eye patients in Florida

Doses of the Genentech Inc. cancer drug Avastin repackaged at a Florida pharmacy for patients with an eye disease caused blindness and other serious eye infections, according to the Food and Drug Administration.
The news could boost the contention of South San Francisco-based Genentech that Avastin should not be broken down into smaller doses for off-label use against wet age-related macular degeneration. The drug, though designed to fight various forms of cancer, is the most-prescribed treatment for that eye disease because its mechanism of action is the same as a more-expensive Genentech drug, Lucentis.

Genentech: Keep Avastin available for 'appropriate' breast cancer patients

Avastin should remain available to patients who need it most while Genentech undertakes another trial, the South San Francisco-based biotech company wrote in what amounts to the final argument in its appeal to maintain Food and Drug Administration approval in metastatic breast cancer.
In paperwork submitted Thursday to the FDA, Genentech said Avastin in combination with the chemotherapy drug paclitaxel should continue to be available while new labeling directs doctors to the “most appropriate” cases where breast cancer has spread to other parts of the body. It also said officials emphasize to doctors and patients the drug’s efficacy and safety data, “thus supporting informed decision-making regarding Avastin.”
Ultimately, FDA Commissioner Margaret Hamburg will decide yet this year whether to end approval of the world's best-selling cancer drug for women with metastatic breast cancer.

Genentech finds diagnostic companions on road to drug development

Perhaps Genentech has a new slogan in the works: Have companion diagnostic, will travel.
The South San Francisco-based U.S. subsidiary of Swiss drug maker Rochefor the past couple years has mandated its research arm to tie in companion diagnostics with drug development. That extends to Genentech partnerships as well, said James Sabry, vice president of partnering for Genentech.

Reaction to FDA's Avastin decision

Here's some of the reaction from Wednesday's Food and Drug Administration advisory panel recommendation to revoke approval of Avastin, developed by South San Francisco's Genentech, for women with metastatic breast cancer.

FDA panel votes against Genentech's Avastin

A regulatory panel recommended Wednesday that approval of Genentech Inc.’s cancer-fighting drug Avastin be revoked for women with breast cancer that has spread to other parts of the body.
The Food and Drug Administration panel in a 6-0 vote said two followup clinical trials did not verify the clinical effect of Avastin for women with metastatic breast cancer.
The final say rests with FDA Commissioner Margaret Hamburg, likely later this summer. The decision could shave about $1 billion in revenue off of Avastin, the world’s best-selling cancer drug.

Bitten by Avastin, will FDA shy away from conditional approvals?

Should Genentech ’s cancer-fighting drug Avastin stay on the market for women with metastatic breast cancer?
When all is said and done, this decision comes down to statistics and rules, and as one speaker said Tuesday, the same rules that allow accelerated approval allow accelerated disapproval. The same FDA and the same Richard Pazdur allowed Avastin onto the market conditionally; they opened the door based on statistics that said women could benefit from Avastin.
They also can close that door, again based on cold, hard numbers, not emotion.
But what's the fallout on companies using the accelerated approval process in the future, and what's the impact on the FDA?

Avastin protest videos: Outrage, emotion and Dylan

They took a while to upload, but here — finally — are the videos I shot of Tuesday morning's protest in support of Genentech 's cancer drug Avastin.
Protesters gathered around 7 a.m., in advance of the Food and Drug Administration's hearing Tuesday and Wednesday on the agency's plan to rescind Avastin's conditional approval for metastatic breast cancer. One of the highlights was a '60s-like protest song that might make Bob Dylan proud.

Day 1: Avastin patients, families protest ahead of FDA hearing

Genentech Inc. ’s cancer-fighting Avastin is in front of a Food and Drug Administration panel today, a struggle that has inspired breast cancer patients and their families.
The hearing — today and Wednesday at the FDA campus in Silver Spring, Md. — will go a long way toward determining if Avastin will win full approval for metastatic breast cancer patients.
Thirty-five people signed up to make public presentations, said Karen Midthun of the FDA, who is presiding over the hearing.
Final submissions by Genentech and the FDA will continue until July 28. FDA Commissioner Margaret Hamburg will make the final decision.

In reversal, European committee says combo of Genentech's Avastin and Roche chemo agent should be approved

Roche’s best-selling cancer drug Avastin should be approved in combination with the chemotherapy agent Xeloda as a first-line treatment for women with metastatic breast cancer, a committee that advises European regulators said in a reversal.
The “positive opinion” from the Committee for Medicinal Products for Human Use, or CHMP, is an important step toward expanding Avastin’s use in Europe, where the drug already is approved in combination with paclitaxel as a first-line treatment for women who can’t take chemotherapy options such as taxanes and anthracyclines.

Genentech's Lucentis works well in trial — but all eyes on NIH study

The Genentech Inc. eye drug Lucentis performed well in a late-stage study of patients with diabetic macular edema — a treatment that could be rejected in the United Kingdom — but the real insight could come next quarter.

European Commission OKs Avastin for one use, rescinds it for another

The European Commission approved the use of the world’s best-selling cancer drug, Avastin, in combination with paclitaxel as a treatment for women with metastatic breast cancer, but rescinded its use with docetaxel.

Avastin gets FDA hearing in June

Genentech Inc. will get its day — actually two — in front of the Food and Drug Administration to plead its case for keeping Avastin as a treatment for women with metastatic breast cancer.

The hearing, scheduled for June 28-29, comes after the FDA in December said it would yank its conditional approval of Avastin for use by women with breast cancer that has spread to other parts of the body.

Trial shows Avastin helps ovarian cancer patients live longer

Komen president: Avastin position unchanged

Study links Genentech's Avastin to deadly side effects

Genentech fires back at FDA over Avastin breast cancer rejection