FDA an­a­lysts picked apart the da­ta, high­light­ed an ab­sence of over­all sur­vival ben­e­fit and not­ed that As­traZeneca had yet to hit the mark re­quired for ear­li­er pan­cre­at­ic can­cer drug ap­provals — but it didn’t make any dif­fer­ence in the end. Short­ly af­ter a slight ma­jor­i­ty of ex­pert ad­vis­ers vot­ed 7 to 5 in fa­vor of us­ing Lyn­parza as a main­te­nance ther­a­py for germline BR­CA-mu­tat­ed metasta­t­ic ade­no­car­ci­no­ma of the pan­creas af­ter 16 weeks of dor­man­cy, the FDA fol­lowed up with a for­mal sanc­tion of its own on Mon­day.

Dave Fredrick­son

The move fur­ther so­lid­i­fies the lead­ing po­si­tion As­traZeneca and Mer­ck hold in the PARP field as Lyn­parza con­tin­ues to rack up new suc­cess­es in on­col­o­gy. This new OK fol­lows land­mark ap­provals in ovar­i­an and breast can­cer as the ma­jor league part­ners line up new fields to con­quer with a drug that tar­gets a re­pair path­way for cells.

The reg­u­la­to­ry bar is set par­tic­u­lar­ly low in on­col­o­gy, and that’s es­pe­cial­ly true for hard-to-treat cas­es like pan­cre­at­ic can­cer, where sur­vival ben­e­fits are low. The ap­proval was large­ly based on da­ta in­di­cat­ing a longer span of pro­gres­sion-free sur­vival for pa­tients, though reg­u­la­tors not­ed is­sues with the tri­al used to gain the OK. But Lyn­parza is well known to the FDA, mak­ing it eas­i­er to take a fly­er on it.

Dave Fredrick­son, As­traZeneca’s EVP of the on­col­o­gy busi­ness unit, said:

Pa­tients with ad­vanced pan­cre­at­ic can­cer his­tor­i­cal­ly have faced poor out­comes due to the ag­gres­sive na­ture of the dis­ease and lim­it­ed treat­ment ad­vances over the last few decades. Lyn­parza is now the on­ly ap­proved tar­get­ed med­i­cine in bio­mark­er-se­lect­ed pa­tients with ad­vanced pan­cre­at­ic can­cer.

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.