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Lilly's middling lung cancer drug wins FDA approval with a restrictive label
November 24, 2015 | By Damian Garde
Eli Lilly ($LLY) won FDA approval for a lung cancer treatment that posted only a marginal survival benefit in late-stage clinical trials, gaining clearance to treat a small population of patients with particularly serious disease.
The antibody therapy, necitumumab, is approved to be dosed alongside two types of chemotherapy for patients with lung cancer that has spread elsewhere in the body. The treatment, to be marketed as Portrazza, is indicated only for patients with squamous non-small cell lung cancer--which accounts for about one-quarter of all lung cancer diagnoses--who haven't received any form of therapy.
Portrazza's limited label is the result of some so-so results in Phase III. A combination of Lilly's treatment and gemcitabine and cisplatin extended patients' lives by just 1.6 months compared with the old chemotherapies alone, and Portrazza's positive effect on progression-free survival amounted to less than a week. The treatment failed to demonstrate any significant benefit in a trial on the more common nonsquamous NSCLC.
Status: Closed
Active, not recruiting
The study is ongoing (that is, participants are receiving an intervention or being examined), but potential participants are not currently being recruited or enrolled.
Changes to NCT01984255 on 2015_11_10
https://clinicaltrials.gov/ct2/help/glossary/recruitment-status
Good morning all we are a day closer to Bavi approval. Looking forward to the weeks and months ahead. Enjoy your day.
The science supports this.
Make a splash get in @1.14
Picked up some knew knowledge and understanding from video. Thanks
AH but imminent will reign one day soon.
RCJ I like the word imminent. Just down the road a piece.
Excellent explanation, break down and comparisons of MOA interrelationships. Believe more folks are understanding this science better each and every day.
Yes read all about it Crazy stuff Delete please
Got to feel good in AH with KBIO HUH?
Volgoat,
Your timelines are too far out. It will be sooner. CP has already provided a good explanation. Fast-track provides several benefits.
Ever closer is about 15 mnths now and then however many mnths to file BLA and get FDA decison. Another 6\9 mnths on top of that? So 2 years?
Looking forward to all commentary a few short months from now.
My view. IMO
1) I stand by my prediction, 2015 dead money.
MY shares are still breathing.
2) Phase I data is worthless no matter how impressive.
AT minimum a supportive BLA entry for SUNRISE
3) No cash partnership without Phase III data which is at least eight months away.
Cash partnership after 2nd interim lookin very possible
Nice read MH EOM
AIK Thanks for reminder. Exciting times for bavi.
Looking forward to your commentary a few short months from now.
Good riddens
ZACKS INVESTMENT MANAGEMENT 09/30/2015 0(148,207)Sold Out
HMMM ok never mind
Dakota Financial News? - 18 hours ago
According to Zacks, “Peregrine Pharmaceuticals, Inc. is a ... Finally, FBR & Co. reiterated an “outperform” rating on shares of Peregrine Pharmaceuticals in a research note on ...
I see HOLD with Zacks
PPHM
$1.20
+0.03 (2.07%)
Volume: 1,655492
Nov 11, 2015 2:50 ET
Save at ZACKS Trade
Mkt Cap$250.41 M
P/E RatioNA
Ind Rank92 / 265
Zacks Rank:Hold 3
While at the AZ booth I posed the question, what would be an anticipated advantage of collaborating with the small biotech across the way? (own AZ shares)
Answer: AZ secures partners that can potentially advance our research to improve our treatment regimens. (Not an exact quote reworded to make a point)
(My interpretation)
The infliction in his voice seemed to denote..
"We strategically choose those collaborations that ensure high probability."
Heading out for the day.
Bio take a walk your fingers must be getting tired.
FDA approval on its way.
Keep up the relevant posting your contributions are adding up. We are very close indeed.
Every negative post forces me to dig deeper and I make it sort of my mission to try and deliver something of value for every non-valued post that appears and that is why I probably can never sleep : )
Here are the words to bold adaptive immunity
Developing inate characteristics could be a key to keeping cancer at bay/non re-occurrence.
If this continues to materializes out of the science this would be a game changer.
Is this right?
Half way down, This sustained T-cell mediated killing of tumor cells is proving bavituximab produces an adaptive immunity not scene in PD-1, PD-L1 or CT-L4 agents.
Did you mean not seen?
I am going to inquire about this at the booth today to get a better understanding of this aspect of the moa
Paul,
You hit all of the salient points. The ensuing months ahead will be interesting.
No go for me this evening. Entrenched in the office until 8PM tonight. I'll be going tomorrow instead. Enjoy dinner and black tea
The classic "Baghdad Bob moment".
Quote: Sahaf's nickname, "Baghdad Bob," now denotes someone who confidently declares what everyone else can see is false.
pphm being > $10 is a nice dream, similar to planning where to spend your lotto winnings
Thanks for efforts and article Chris
Yes I agree Friday's session looks more informative. Uncertain for me. Need to reshuffle some things to consider this. I'll follow up later in day if this works. Either way hopefully one of us or somebody else can be there to enlighten the board with feedback.
A little snip from a Fierce Biotech article
Durvalumab is AstraZeneca's most important pipeline product and the company said last year, during its bid defense against a takeover attempt by Pfizer, that the medicine could eventually generate annual sales of $6.5 billion, making it a key component of an overall $45 billion sales forecast for 2023.
While ATLANTIC is looking at durvalumab's use on its own in a subset of late-stage lung cancer patients, Soriot said the drug's real promise lay in combining it with other products to help a much wider range of patients.
Good to know Jeff. Thanks
Those are possible retirement numbers. But first things first approval.
I think I'll go to ticket desk on Saturday morning and give this a go. Unable to make it the other days.
Good atmosphere, restaurants & bars if all fails.
North
Checked with some contacts to try and get in through them.
received word already. No go this time.
Contact Show Care for admission: 866-320-3203
Cost: Non industry-non membership for duration all days $850.00 and for any one day $350.00 per individual.
North I am right down the Potomac I am trying to navigate this. Missed registration cut off this year. If I get any traction I'll give you a heads up. Should know by Friday. We have not met so this would be interesting.
North I am right down the Potomac I am trying to navigate this. Missed registration cut off this year. If I get any traction I'll give you a heads up. Should know by Friday. We have not met so this would be interesting.
I'm rooting for TessiMay
TessiMay - 12/31/15 = $23.99 -- 6/30/16 = $88.69
Looking forward to your views several months from now. Especially a year from now.
Looking forward to your analogy a year from now.
Couch
Good reminder.
Sorry but the stock isn't selling at the pre reverse split level of 23.4 cents....the stock is selling at $1.17 so that is indeed misinformation.
And I'll let the scientific community speak for itself on the second mistaken assumption.
Robert Iannone, Head of Immuno-Oncology, Global Medicines Development, at AstraZeneca said, "We believe that combination therapy in immuno-oncology has the potential to be a novel and highly effective approach to treating cancer. Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers."
The studies at MSK will be performed under the direction of Taha Merghoub, Ph.D., Associate Attending Biologist, Melanoma and Immunotherapeutics Service, Ludwig Collaborative and the Swim Across America Laboratory, a part of the laboratory of Jedd D. Wolchok, M.D., Ph.D., a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Chief, Melanoma and Immunotherapeutics Service, Lloyd J. Old Chair for Clinical Investigation as well as an Associate Director of the Ludwig Center for Cancer Immunotherapy at MSK.
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Wolchok.
OK that makes better sense at least. Thanks
Miltefosine (INN, trade names Impavido and Miltex) is a broad-spectrum phospholipid antimicrobial drug.
This does not apply either: Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.
Indeed a strange adjective to use for Avid:
English meaning:impavido
undaunted - unfazed - unflappable - deadpan - unemotional - unperturbed - unflinching