Product Development

Roche’s cobas EGFR liquid biopsy use suffers in light of popular panel tests as NSCLC landscape evolves, experts say

Roche’s (SIX:ROG) cobas EGFR Mutation Test v2 liquid biopsy diagnostic used with and after initial treatment with its own drug Tarceva (erlotinib) is becoming increasingly redundant as more physicians choose AstraZeneca’s (LON:AZN) Tagrisso (osimertinib) for first-line (1L) treatment of EGFR mutant non-small cell lung cancer (NSCLC).

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Tyme’s future Phase III needs to focus on patient subsets due to BCR prostate cancer heterogeneity; early Phase I/II SM-88 data provide limited foresight potential, experts say

Tyme Technologies’ (NASDAQ:TYME) potential Phase III trial investigating SM-88 in biochemically recurrent (BCR) prostate cancer should zero in on niche populations for trial success due to significant heterogeneity between such patients, experts said.

While three experts noted specifically enrolling patients according to prostate-specific antigen (PSA) doubling time—a BCR prostate cancer diagnostic test—could be helpful, one expert said classification according to genomic features can be challenging due to cell differences between tumour cells.

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Spark has submitted updated Phase I/II choroideremia data for ARVO meeting in April; earlier-stage patients show improved albeit nonstatistically significant efficacy, exec says

Spark has submitted updated Phase I/II choroideremia data for ARVO meeting in April; earlier-stage patients show improved albeit nonstatistically significant efficacy, exec says

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Sarepta's golodirsen DMD data elicit lackluster expert interest for accelerated approval; clinical benefits from Phase I/II dystrophin increase expected to be mild

Sarepta Therapeutics’ (NASDAQ:SRPT) Phase I/II SRP-4053 (golodirsen) data is not strong enough for approval in Duchenne’s muscular dystrophy, experts said.

On 20 December, Sarepta announced that it had finished its rolling NDA for accelerated approval of golodirsen in DMD patients who have genetic mutations subject to skipping exon 53. One analyst report noted a likely approval based on the data’s strength; another analyst stated the results show a modest benefit but pointed out there is a lack of treatment options.

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Eli Lilly Verzenio usage split roughly three-ways in HR+ breast cancer, exec says

Eli Lilly’s (NYSE:LLY) Verzenio (abemaciclib) usage within its three labelled indications in hormone receptor-positive (HR+) breast cancer has been approximately 20% as a late-line monotherapy, 30% as an initial therapy in combination with anastrozole, and 40% in combination with AstraZeneca’s (LON:AZN) Faslodex (fulvestrant), said Alex Horn, global development leader for Abemaciclib, Eli Lilly, Indianapolis.

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Arena’s Phase II etrasimod has welcome anti-inflammatory MOA for PBC but may be nonspecific, data in UC inapt for extrapolation, experts say

Although Arena Pharmaceuticals’ (NASDAQ:ARNA) etrasimod has a logical anti-inflammatory mechanism for potential Phase II success in primary biliary cholangitis (PBC), experts also noted the same mechanism may lack specificity to have clear impact on the autoimmune disease.

While there is etrasimod Phase II data in ulcerative colitis (UC), it is unlikely to be areliable gauge for potential efficacy in PBC due to disease differences, even if both have inflammatory disease elements, experts noted.

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J&J's Darzalex Phase III first-line MM data at ASH to bolster drug’s use in clinical practice immediately, experts say

Johnson & Johnson's (NYSE:JNJ) MAIA Phase III data of Darzalex (daratumumab) in front-line multiple myeloma (MM) could have an immediate impact on clinical practice in the US, experts said on the sidelines of the recently concluded American Association of Hematology (ASH) annual meeting.

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Future NASH reimbursement road bumps may echo HCV path; biopsies, high fibrosis stage to limit drug access, experts say

Nonalcoholic steatohepatitis (NASH) therapies with prospective launches post-2020 will likely have reimbursement challenges mirroring those faced by hepatitis C (HCV) therapies approved five years ago, experts said. They expect payers to establish ultrarestrictive criteria to limit access, including biopsy confirmations and only reimbursing severe fibrosis patients.

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Foamix’s FMX103 has split views on sunburn risk for facial papulopustular rosacea, although approval expected, experts say

Foamix Pharmaceuticals’ (NASDAQ:FOMX) FMX103 (1.5% topical minocycline foam) has experts split over the drug’s real-world ability to protect against sunburn, despite expected FDA approval for moderate-to-severe facial papulopustular rosacea.

FMX103 likely makes the skin more sensitive to sunburn, which can result in scars for this patient population already affected by pustules on their face, said one expert.

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Allergan keeps investigators waiting for abicipar’s full Phase III data of CEDAR/SEQUOIA in nAMD; skepticism surrounds reformulation in MAPLE trial

Two investigators on Allergan’s (NYSE:AGN) abicipar trials in neovascular age-related macular degeneration (nAMD)—CEDAR and SEQUOIA—have said the company has still not shared full trial data to investigators, noting this as a longer-than-expected delay. Such delays are increasing the existing caution on the overall drug profile given already lingering anxieties surrounding toxicities and abicipar’s MOA. Its ongoing MAPLE trial of a new formulation of abicipar also continues to generate doubt, with abicipar’s fundamental mechanism potentially being the root of safety issues, they added.

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